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"
3337–3360 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Aug 25, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
K992165 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 58d
Cleared Aug 25, 1999
BIOSHIELD EXPRESS STERILIZATION WRAP
K983719 · FRG
Allegiance Healthcare Corp.
General Hospital · 308d
Cleared Aug 23, 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
K992299 · LZA
Pamitex Industries Sdn Bhd
General Hospital · 46d
Cleared Aug 12, 1999
CONVERTORS BREATHABLE SURGICAL GOWNS
K992514 · FYA
Allegiance Healthcare Corp.
General Hospital · 15d
Cleared Aug 09, 1999
ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
K992428 · LYY
Tillotson Healthcare Corp.
General Hospital · 19d
Cleared Jul 26, 1999
LUER ACCESS INJECTION SITE
K984060 · FPA
Baxter Healthcare Corp
General Hospital · 255d
Cleared Jul 22, 1999
QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
K992207 · DIO
Syntron Bioresearch, Inc.
Toxicology · 22d
Cleared Jul 13, 1999
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
K991992 · KGO
Allegiance Healthcare Corp.
General Hospital · 29d
Cleared Jul 12, 1999
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
K991300 · BWF
Dhd Healthcare Corp.
Anesthesiology · 87d
Cleared Jun 25, 1999
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
K991928 · GCJ
Allegiance Healthcare Corp.
General & Plastic Surgery · 17d
Cleared Jun 24, 1999
LATEX EXAMINATION GLOVES (PRE POWDERED)
K991690 · LYY
Usg Healthguard Sdn Bhd
General Hospital · 37d