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
3625–3648 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 12, 2014
BAHADIR STERILIZATION TRAYS
K131407 · KCT
Bahadir USA Corp.
General Hospital · 454d
Cleared Aug 08, 2014
BLUE NITRILE POWDER FREE EXAM GLOVES
K133325 · LZA
Shandong Xinshi Medical Products Co.,...
General Hospital · 283d
Cleared Aug 07, 2014
KIMGUARD ONE-STEP STERILIZATION WRAP
K141612 · FRG
Kimberly-Clark Health Care
General Hospital · 52d
Cleared Aug 07, 2014
SPORVIEW PLUS BI TEST PACK
K140620 · FRC
Crosstex International
General Hospital · 149d
Cleared Aug 07, 2014
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K133168 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 294d
Cleared Aug 05, 2014
SAPPHIRE ADMINISTRATION SET
K141834 · FPA
Q Core Medical , Ltd.
General Hospital · 29d
Cleared Aug 05, 2014
TURBO-JECT PICC SETS
K141818 · LJS
Cook Corporated
General Hospital · 29d
Cleared Aug 05, 2014
Terumo Pen Injector Needle 34
K140516 · FMI
Kofu Factory of Terumo Corp.
General Hospital · 158d
Cleared Aug 05, 2014
INTRAVASCULAR ADMINISTRATION SET
K140175 · FPA
Delta Med Spa
General Hospital · 194d
Cleared Aug 01, 2014
SMC ACUPUNCTURE NEEDLE
K141473 · MQX
Smc Intl., Inc.
General Hospital · 59d
Cleared Aug 01, 2014
ENDOSCOPE STERILIZATION TRAY
K133942 · KCT
Intuitive Surgical
General Hospital · 221d
Cleared Jul 30, 2014
ELCAM STOPCOCKS AND MANIFOLDS
K141254 · FMG
Elcam Medical Acal
General Hospital · 77d
Cleared Jul 30, 2014
LEADERFLEX
K141026 · FOZ
Vygon
General Hospital · 99d
Cleared Jul 30, 2014
VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
K132709 · CAH
Vr Medical
General Hospital · 335d
Cleared Jul 29, 2014
CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
K141749 · FMI
Facet Technologies, LLC
General Hospital · 29d
Cleared Jul 28, 2014
KIMGUARD ONE-STEP STERILIZATION WRAP
K141071 · FRG
Kimberly-Clark Health Care
General Hospital · 94d
Cleared Jul 25, 2014
HARD PACK SYRINGE
K141359 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 63d
Cleared Jul 25, 2014
0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH
K141311 · NGT
Becton, Dickinson and Company
General Hospital · 66d
Cleared Jul 25, 2014
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER...
K141193 · PHC
Smiths Medical Asd, Inc.
General Hospital · 78d
Cleared Jul 25, 2014
V-PRO STERILIZATION TRAY/ STERILIZATION MAT
K140494 · KCT
STERIS Corporation
General Hospital · 148d
Cleared Jul 25, 2014
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
K140250 · KKX
3M Healthcare
General Hospital · 175d
Cleared Jul 24, 2014
COLONGLIDE LUBRICANT
K141028 · KMJ
Pediatric Pharmaceuticals, Inc.
General Hospital · 93d
Cleared Jul 24, 2014
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE...
K140890 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 107d
Cleared Jul 24, 2014
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
K140498 · MLR
STERIS Corporation
General Hospital · 147d