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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
2641–2664 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 21, 2007
SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
K063043 · FXX
Modern Healthcare Corp.
General Hospital · 169d
Cleared Mar 20, 2007
SUNPOLAR HEALTHLINE, MODEL 100
K062873 · DWL
E.C.I. USA Corporation
General Hospital · 176d
Cleared Mar 19, 2007
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
K070420 · ODD
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 13, 2007
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02
K070421 · MSX
Ge Healthcare
Cardiovascular · 28d
Cleared Mar 06, 2007
FORCETRIAD ELECTROSURGICAL GENERATOR
K070162 · GEI
Valleylab,A Division of Tyco...
General & Plastic Surgery · 48d
Cleared Mar 02, 2007
WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095
K070139 · MSH
Survivair, Inc.
General Hospital · 45d
Cleared Mar 01, 2007
MAXHEALTH MECHANICAL WHEELCHAIR, K1
K070176 · IOR
Maxhealth Corp.
Physical Medicine · 42d
Cleared Feb 27, 2007
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
K063696 · FRN
Baxterhealthcare, Inc.
General Hospital · 76d
Cleared Feb 23, 2007
SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X
K070268 · FRN
Cardinal Health 303,Inc.
General Hospital · 25d
Cleared Feb 23, 2007
3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870
K063023 · MSH
3M Company
General Hospital · 144d
Cleared Feb 23, 2007
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
K062263 · CAF
Omron Healthcare, Inc.
Anesthesiology · 203d
Cleared Feb 21, 2007
C300 SERIES AIR NEBULIZER COMPRESSOR
K062952 · CAF
Choice Smart Health Care Co. , Ltd.
Anesthesiology · 145d
Cleared Feb 13, 2007
BODIHEALTH SYSTEM
K052836 · GZJ
Usa Laser Therapeutics, Inc.
Neurology · 495d
Cleared Feb 07, 2007
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
K063660 · NUH
Well-Life Healthcare Limited
Neurology · 61d
Cleared Feb 01, 2007
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL...
K063855 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 35d
Cleared Jan 31, 2007
REPROCESSED TROCARS
K062497 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 159d
Cleared Jan 29, 2007
POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
K063536 · GAM
Tyco Healthcare Group
General & Plastic Surgery · 68d
Cleared Jan 25, 2007
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
K061554 · FRO
Molnlycke Health Care
General & Plastic Surgery · 234d
Cleared Jan 25, 2007
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
K052973 · FRN
Baxter Healthcare Corp
General Hospital · 458d
Cleared Jan 12, 2007
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS...
K063747 · MSH
Inovel, LLC
General Hospital · 24d
Cleared Jan 08, 2007
POWERTONE, MODEL PT-11
K062439 · NGX
Johari Digital Healthcare , Ltd.
Physical Medicine · 140d
Cleared Dec 29, 2006
MODIFICATION TO HEALTH BUDDY APPLIANCE
K063612 · DRG
Health Hero Network, Inc.
Cardiovascular · 25d
Cleared Dec 28, 2006
CLINITEK ADVANTUS, MODEL 1420
K063276 · JIL
Bayer Healthcare, LLC
Chemistry · 59d
Cleared Dec 26, 2006
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
K063628 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 20d