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"
3313–3336 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 11, 2000
KODAK HOME HEALTH MONITORING SYSTEM
K983928 · MWI
Eastman Kodak Company
Cardiovascular · 463d
Cleared Feb 10, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE...
K993918 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 84d
Cleared Feb 09, 2000
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING...
K994162 · LYY
Allegiance Healthcare Corp.
General Hospital · 62d
Cleared Jan 27, 2000
GAMBRO DQM 200
K990039 · LFP
Gambro Healthcare
Chemistry · 386d
Cleared Jan 24, 2000
BABY DOPPLEX 4000, MODEL BD 4000
K990569 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 335d
Cleared Jan 14, 2000
INFRARED EAR THERMOMETER, MODEL KI-8120
K984551 · FLL
K-Jump Health Co., Ltd.
General Hospital · 388d
Cleared Jan 12, 2000
CONVERTORS SURGICAL DRAPES
K993795 · KKX
Allegiance Healthcare Corp.
General Hospital · 64d
Cleared Dec 29, 1999
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES,...
K993621 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 64d
Cleared Dec 20, 1999
ALATECH LATEX CONDOM
K993887 · HIS
Alatech Healthcare, LLC
Obstetrics & Gynecology · 34d
Cleared Dec 10, 1999
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
K993833 · BZE
Allegiance Healthcare Corp.
Anesthesiology · 28d
Cleared Dec 03, 1999
HL148 & HL168
K990807 · DXN
Health & Life Co., Ltd.
Cardiovascular · 267d
Cleared Nov 24, 1999
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared Nov 23, 1999
HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
K993128 · CGA
Health Hero Network, Inc.
Chemistry · 64d
Cleared Nov 17, 1999
MODIFIED BLOOD RECIPIENT SET
K993120 · BRZ
Baxter Healthcare Corp
General Hospital · 58d
Cleared Nov 10, 1999
ROADRUNNER, PEP THERAPY DEVICE
K991561 · BWF
Dhd Healthcare Corp.
Anesthesiology · 190d
Cleared Nov 05, 1999
MODIFICATION TO MP-3 POWER BASE CHAIR
K993032 · ITI
Merits Health Products., Inc.
Physical Medicine · 87d
Cleared Nov 01, 1999
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
K993387 · FRN
Baxter Healthcare Corp
General Hospital · 24d
Cleared Oct 29, 1999
QUICKPAC II ONE STEP OPIATES TEST
K993491 · DJG
Syntron Bioresearch, Inc.
Toxicology · 14d
Cleared Oct 29, 1999
QUICKSTRIP ONE STEP OPIATES TEST
K993490 · DJG
Syntron Bioresearch, Inc.
Toxicology · 14d
Cleared Oct 29, 1999
HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
K993093 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 43d
Cleared Oct 27, 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH...
K993097 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 41d
Cleared Oct 27, 1999
NEXT GENERATION RODDING SYSTEM
K992784 · KWQ
United States Surgical, A Division of...
Orthopedic · 69d
Cleared Oct 18, 1999
HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE...
K992523 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 82d
Cleared Oct 15, 1999
PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K992478 · DXN
Hewlett-Packard, Healthcare Solutions...
Cardiovascular · 81d