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"
3361–3384 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 24, 1999
LATEX EXAMINATION GLOVES (POWDER FREE)
K991689 · LYY
Usg Healthguard Sdn Bhd
General Hospital · 37d
Cleared Jun 23, 1999
DEXIDE BIPOLAR FORCEPS II ** DEVICE
K991859 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 22d
Cleared Jun 23, 1999
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K991304 · LZA
M.R.G. Industries Sdn. Bhd.
General Hospital · 68d
Cleared Jun 21, 1999
HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
K991305 · LYY
M.R.G. Industries Sdn. Bhd.
General Hospital · 66d
Cleared Jun 18, 1999
RENAL LINK
K990953 · KPF
Baxter Healthcare Corp
Gastroenterology & Urology · 88d
Cleared Jun 11, 1999
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
K991831 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 14d
Cleared Jun 11, 1999
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
K991215 · EFQ
Symtex Healthcare Corp.
General & Plastic Surgery · 63d
Cleared Jun 04, 1999
AUTO SUTURE ABBI SYSTEM
K983296 · KNW
United States Surgical, A Division of...
Gastroenterology & Urology · 256d
Cleared May 28, 1999
HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
K991640 · LZA
M.R.G. Industries Berhad
General Hospital · 16d
Cleared May 18, 1999
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 11d
Cleared May 13, 1999
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
K991484 · BTT
Allegiance Healthcare Corp.
Anesthesiology · 15d
Cleared Apr 21, 1999
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
K982413 · KDI
Gambro Healthcare
Gastroenterology & Urology · 282d
Cleared Apr 16, 1999
CONVERTORS SURGICAL GOWNS
K991034 · FYA
Allegiance Healthcare Corp.
General Hospital · 18d
Cleared Apr 05, 1999
GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH
K990567 · FRG
Global Healthcare, Inc.
General Hospital · 41d
Cleared Apr 02, 1999
THERAPEP
K983467 · BWF
Dhd Healthcare Corp.
Anesthesiology · 189d
Cleared Apr 02, 1999
ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT...
K982505 · LYY
Tillotson Healthcare Corp.
General Hospital · 256d
Cleared Apr 01, 1999
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
K990952 · GAT
United States Surgical, A Division of...
General & Plastic Surgery · 10d
Cleared Apr 01, 1999
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
K990951 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 10d
Cleared Mar 26, 1999
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
K982414 · KDI
Gambro Healthcare
Gastroenterology & Urology · 256d
Cleared Mar 19, 1999
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
K983572 · MNR
Healthdyne Technologies, Inc.
Anesthesiology · 157d
Cleared Mar 11, 1999
MABIS NB-02 ULTRASONIC NEBULIZER
K990506 · CAF
Mabis Healthcare, Inc.
Anesthesiology · 22d
Cleared Mar 03, 1999
MEPITEL NON ADHERENT SILICONE DRESSING
K984371 · MGP
Molnlycke Health Care, Inc.
General & Plastic Surgery · 86d
Cleared Mar 01, 1999
HYPERGEL 20% HYPERTONIC SALINE GEL
K984370 · MGQ
Molnlycke Health Care, Inc.
General & Plastic Surgery · 84d
Cleared Feb 24, 1999
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100...
K980386 · KDI
Gambro Healthcare
Gastroenterology & Urology · 387d