FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,281 results for "health"
3409–3432 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Oct 13, 1999
ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT...
K991205 · KGO
Allegiance Healthcare Corp.
General Hospital · 187d
Cleared Oct 07, 1999
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K984590 · FOZ
Baxter Healthcare Corp
General Hospital · 283d
Cleared Oct 06, 1999
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE,...
K991474 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 162d
Cleared Oct 05, 1999
DEXIDE BIPOLAR FORCEPS II** DEVICE
K993055 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 22d
Cleared Sep 29, 1999
SPRING POWERLITE 2000
K992728 · EBZ
Spring Health Products, Inc.
Dental · 47d
Cleared Sep 22, 1999
CONVERTORS SURGICAL GOWNS
K992951 · FYA
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Sep 22, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH...
K992364 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 69d
Cleared Sep 20, 1999
QUICKPAC II ONE STEP COCAINE TEST
K992990 · DIO
Syntron Bioresearch, Inc.
Toxicology · 13d
Cleared Sep 14, 1999
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT...
K992171 · KGO
Allegiance Healthcare Corp.
General Hospital · 78d
Cleared Sep 09, 1999
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH...
K991969 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 90d
Cleared Sep 03, 1999
SHINMED MODEL SW-966 ULTRASONIC NEBULIZER
K980024 · CAF
Shining World Health Care Co., Ltd.
Anesthesiology · 606d
Cleared Sep 02, 1999
DRUGCHECK X MULTIDRUG SCREENING DEVICE
K992748 · DIO
Syntron Bioresearch, Inc.
Toxicology · 17d
Cleared Aug 30, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE
K992223 · LZA
Pamitex Industries Sdn Bhd
General Hospital · 60d