Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
2281–2304 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 06, 2020
ClearMask Transparent Surgical Face Mask
K200576 · FXX
Clearmask, LLC
General Hospital · 32d
Cleared Apr 06, 2020
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs...
K200019 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 94d
Cleared Apr 06, 2020
SensiCare PI and SensiCare PI Micro Surgical Gloves
K193217 · KGO
Medline Industries, Inc.
General Hospital · 137d
Cleared Apr 03, 2020
RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single...
K200577 · NVE
STERIS Corporation
General Hospital · 29d
Cleared Apr 02, 2020
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin...
K200319 · FMT
Deroyal Industries, Inc.
General Hospital · 55d
Cleared Apr 02, 2020
QwikCheck Chemical Indicators
K192445 · JOJ
Serim Research Corporation
General Hospital · 209d
Cleared Apr 01, 2020
Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove...
K192988 · KGO
Medline Industries, Inc.
General Hospital · 159d
Cleared Apr 01, 2020
Introcan Safety 2 IV Catheter 18-24 gauge
K192676 · FOZ
B.Braun Medical, Inc.
General Hospital · 188d
Cleared Apr 01, 2020
CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical...
K192228 · PSW
Cs Medical, LLC
General Hospital · 229d
Cleared Mar 31, 2020
Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis...
K191860 · KGO
Semperit Technische Produkte...
General Hospital · 264d
Cleared Mar 30, 2020
System 83 Plus Washer/Disinfector
K173590 · FEB
Custom Ultrasonics, Inc.
General Hospital · 860d
Cleared Mar 27, 2020
JJ Series Container System
K192056 · KCT
Aesculap, Inc.
General Hospital · 239d
Cleared Mar 23, 2020
HepaShield Bacterial Viral Breathing System Filter
K191909 · CAH
Flexicare Medical Limited.
General Hospital · 250d
Cleared Mar 21, 2020
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7...
K200493 · FXY
Stryker Corporation
General Hospital · 22d
Cleared Mar 20, 2020
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy...
K193581 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 88d
Cleared Mar 20, 2020
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health...
K193327 · FYA
Cardinal Health200, LLC
General Hospital · 109d
Cleared Mar 20, 2020
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim...
K193121 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 129d
Cleared Mar 19, 2020
IV Sets not made with PVC
K191658 · FPA
B.Braun Medical, Inc.
General Hospital · 272d
Cleared Mar 17, 2020
SterilContainer S2 System
K193582 · KCT
Aesculap, Inc.
General Hospital · 85d
Cleared Mar 17, 2020
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For...
K191753 · LZA
Medline Industries, Inc.
General Hospital · 260d
Cleared Mar 16, 2020
AERO CHROME* Breathable Performance Surgical Gowns
K200522 · FYA
O&M Halyard, Inc.
General Hospital · 14d
Cleared Mar 16, 2020
Altera Filter and HME/Filter
K192713 · CAH
Meditera Tibbi Malzeme San VE Tic AS
General Hospital · 171d
Cleared Mar 13, 2020
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
K193110 · QKM
3M Healthcare
General Hospital · 122d
Cleared Mar 13, 2020
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free...
K192241 · LZA
O&M Haylard, Inc.
General Hospital · 207d