FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
2233–2256 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 20, 2020
CapKlenZ
K192382 · QBP
Star Mountain Medical, Inc.
General Hospital · 234d
Cleared Apr 20, 2020
Rio Vial-to-Bag Drug Reconstitution Device
K192154 · LHI
Icu Medical
General Hospital · 255d
Cleared Apr 15, 2020
Molekule Air Pro RX
K200500 · FRA
Molekule, Inc.
General Hospital · 47d
Cleared Apr 15, 2020
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with...
K200181 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 82d
Cleared Apr 15, 2020
3MTM AttestTM Mini Auto-reader 490M
K200092 · FRC
3M
General Hospital · 90d
Cleared Apr 15, 2020
Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical...
K193561 · FRG
Weihai Xingtai Packaging Products...
General Hospital · 114d
Cleared Apr 14, 2020
UroLift System Procedure Kit Sterilization Tray
K192781 · KCT
Neotract, Inc.
General Hospital · 197d
Cleared Apr 10, 2020
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with...
K200072 · LZA
Kimberly Clark Corporation
General Hospital · 87d
Cleared Apr 10, 2020
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI...
K193573 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 109d
Cleared Apr 10, 2020
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single...
K192679 · MEG
Gemtier Medical (Shanghai), Inc.
General Hospital · 197d
Cleared Apr 09, 2020
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with...
K200539 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 37d
Cleared Apr 09, 2020
Powder Free Nitrile Examination Glove (Aqua Green)
K200326 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 59d
Cleared Apr 08, 2020
TCAT TKA Instrument Tray Set
K200632 · KCT
THINK Surgical, Inc.
General Hospital · 29d
Cleared Apr 07, 2020
BD Centro Vena Acute Central Line (7 French Dual Lumen)
K200266 · FOZ
Bard Access Systems, Inc. (Bard Has...
General Hospital · 64d
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