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
2809–2832 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 07, 2017
IV Administration Sets
K170595 · FPA
B.Braun Medical, Inc.
General Hospital · 252d
Cleared Nov 06, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and...
K172442 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 87d
Cleared Nov 03, 2017
Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle...
K170897 · PTI
B.Braun Medical, Inc.
General Hospital · 221d
Cleared Nov 02, 2017
Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R)...
K163646 · FRC
Terragene S.A.
General Hospital · 314d
Cleared Nov 02, 2017
ORCA (tm) - Operational Rescue Containment Apparatus
K163223 · LGM
Isovac Products, LLC
General Hospital · 351d
Cleared Nov 01, 2017
MAUSER PG II Sharps Container
K170513 · MMK
Mauzer USA, LLC
General Hospital · 253d
Cleared Nov 01, 2017
AN87 Dosimeter
K170439 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 261d
Cleared Nov 01, 2017
Sterisheet Sterilization Wrap
K170437 · FRG
Andersen Sterilizers, Inc.
General Hospital · 261d
Cleared Nov 01, 2017
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short...
K162812 · FPA
Unomedical A/S
General Hospital · 391d
Cleared Oct 31, 2017
Anprolene AN75 Ethylene Oxide Gas Sterilizer
K170432 · FLF
Andersen Sterilizers, Inc.
General Hospital · 260d
Cleared Oct 31, 2017
Anprolene SteriTest
K170427 · FRC
Andersen Sterilizers, Inc.
General Hospital · 260d
Cleared Oct 30, 2017
AN85/AN86 EO Indicators
K170426 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 259d
Cleared Oct 30, 2017
Crystal Vision
K163659 · FYD
I.C Medical, Inc.
General Hospital · 307d
Cleared Oct 27, 2017
Skylife
K170585 · LBI
Neolight, LLC
General Hospital · 241d
Cleared Oct 27, 2017
Tyvek Sterilization Pouches with Chevron Seal
K170429 · FRG
Andersen Sterilizers, Inc.
General Hospital · 256d
Cleared Oct 26, 2017
Celerity ECG Cable Accessory Pack
K171931 · LJS
Medcomp (Medical Components, Inc.)
General Hospital · 120d
Cleared Oct 25, 2017
DentureID Microchip
K170423 · PYQ
Cmp Industries, LLC
General Hospital · 254d
Cleared Oct 25, 2017
iTotal Family Reusable Instrument Tray
K170226 · KCT
Conformis, Inc.
General Hospital · 273d
Cleared Oct 23, 2017
STERILE VINYL EXAMINATION GLOVES, Powder Free
K170612 · LYZ
Primus Gloves Pvt Limited
General Hospital · 236d
Cleared Oct 20, 2017
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
K171987 · KGO
Lucenxia Prescience AG
General Hospital · 109d
Cleared Oct 19, 2017
GRI-FILL PERISTALTIC SET
K162216 · LHI
Laboratorios Grifols, S.A.
General Hospital · 437d
Cleared Oct 13, 2017
PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator
K162362 · FRG
Pms Tibbi Cihazlar Teknolojisi San VE...
General Hospital · 416d
Cleared Oct 12, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin...
K171874 · LZA
Hartalega Sdn Bhd
General Hospital · 111d
Cleared Oct 12, 2017
Vial Adapter 15mm
K171796 · LHI
Medimop Medical Project , Ltd.
General Hospital · 118d