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
3889–3912 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 05, 2013
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K131078 · MED
STERIS Corporation
General Hospital · 79d
Cleared Jul 05, 2013
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
K130473 · LZA
Hartalega Sdn Bhd
General Hospital · 133d
Cleared Jul 05, 2013
TIBURON SURGICAL DRAPE
K130404 · KKX
Cardinal Health200, LLC
General Hospital · 136d
Cleared Jul 05, 2013
AIRVIEW BOWIE DICK
K130211 · JOJ
Spsmedical Supply Corp.
General Hospital · 157d
Cleared Jul 05, 2013
ERMIS STERILIZATION CONTAINER SYSTEM
K123234 · KCT
Ermis Medizintechnik
General Hospital · 263d
Cleared Jun 25, 2013
FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE
K130487 · FMI
Pyng Medical Corp.
General Hospital · 120d
Cleared Jun 21, 2013
HYRDROMAX HMEF
K130664 · CAH
A-M Systems
General Hospital · 101d
Cleared Jun 21, 2013
OAK RIDGE PRODUCTS SHARP CONTAINER
K130281 · MMK
Oak Ridge Products, LLC
General Hospital · 136d
Cleared Jun 18, 2013
DURABLUE STERILIZATION WRAP
K130927 · FRG
Cardinal Health200, LLC
General Hospital · 76d
Cleared Jun 17, 2013
VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
K123590 · LYZ
Weilin Plastic and Rubber Products...
General Hospital · 208d
Cleared Jun 14, 2013
ENFLOW IV FLUID WARMER INSULATED STRAP
K130867 · LGZ
Vital Signs, Inc., A GE Healthcare...
General Hospital · 78d
Cleared Jun 13, 2013
ENTERAL NUTRITION WARMER
K122449 · LGZ
Acacia, Inc.
General Hospital · 304d
Cleared Jun 12, 2013
Z-800 INFUSION SYSTEM
K130690 · FRN
Zyno Medical, LLC
General Hospital · 90d
Cleared Jun 12, 2013
NEXUS TKO-6P LUER ACTIVATED DEVICE
K130416 · FPA
Nexus Medical, LLC
General Hospital · 113d
Cleared Jun 06, 2013
DAS MEDICAL EQUIPMENT DRAPES
K121436 · KKX
Das Medical, LLC
General Hospital · 387d
Cleared Jun 03, 2013
FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
K130507 · LJS
Footprint Medical, Inc.
General Hospital · 96d
Cleared May 30, 2013
IDRIVE ULTRA STERILIZATION TRAY
K130532 · KCT
Covidien, Formerly US Surgical A...
General Hospital · 90d
Cleared May 24, 2013
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
K121898 · FRL
Quick-Med Technologies, Inc.
General Hospital · 329d
Cleared May 23, 2013
ATOM TRANSCAPSULE V-707
K123937 · FPL
Atom Medical Corporation
General Hospital · 154d
Cleared May 23, 2013
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP...
K123084 · FMG
Elcam Medical Acal
General Hospital · 234d
Cleared May 23, 2013
SANICLAVE 102, MODEL RS-SC-102
K122978 · FLE
Alternative Pioneering Research and...
General Hospital · 239d
Cleared May 22, 2013
GETINGE 800HC- SERIES STEAM STERILIZER
K122625 · FLE
Getinge Sourcing, LLC
General Hospital · 267d
Cleared May 20, 2013
ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
K123115 · FXX
Acme Filter Mask, Inc.
General Hospital · 229d
Cleared May 17, 2013
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
K120671 · FLL
Cotronic Technology Limited
General Hospital · 438d