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"
3529–3552 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 14, 1997
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE
K971945 · KGO
Tillotson Healthcare Corp.
General Hospital · 48d
Cleared Jul 09, 1997
POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES
K971381 · KGO
Allegiance Healthcare Corp.
General Hospital · 86d
Cleared Jul 01, 1997
ULTRASONIC HAND INSTRUMENTS
K971861 · LFL
United States Surgical, A Division of...
General & Plastic Surgery · 42d
Cleared Jun 18, 1997
SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT
K964374 · DWF
3M Healthcare
Cardiovascular · 229d
Cleared Jun 18, 1997
SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT
K964373 · DWF
3M Healthcare
Cardiovascular · 229d
Cleared Jun 13, 1997
HBF-1000 OMRON BODY COMPOSITION ANALYZER
K963575 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 280d
Cleared Jun 13, 1997
DEVILBISS 8650D
K963349 · BTI
Devilbiss Health Care, Inc.
Anesthesiology · 291d
Cleared Jun 06, 1997
CONTINU-FLO SOLUTION SET
K971701 · FPA
Baxter Healthcare Corp
General Hospital · 29d
Cleared Jun 06, 1997
EXTRESAFE PHLEBOTOMY
K964042 · FMI
Specialized Health Products, Inc.
General Hospital · 241d
Cleared Jun 04, 1997
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
K971465 · HOY
National Healthcare Mfg. Corp.
General Hospital · 43d
Cleared Jun 03, 1997
AUTO SUTURE* ILM** KIT
K971201 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 63d
Cleared May 27, 1997
CONVERTORS SMS DRAPES
K970554 · KKX
Allegiance Healthcare Corp.
General Hospital · 103d
Cleared May 23, 1997
OCCLUSION CLAMP** DEVICE
K964251 · DXC
United States Surgical, A Division of...
Cardiovascular · 211d
Cleared May 16, 1997
DHD EMERALD PRODUCT
K970596 · BWF
Dhd Diemolding Healthcare Div.
Anesthesiology · 87d
Cleared May 08, 1997
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
K971317 · KDD
National Healthcare Mfg. Corp.
General & Plastic Surgery · 29d
Cleared May 06, 1997
HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT
K964188 · JOW
Healthcare Service and Supply
Cardiovascular · 197d
Cleared May 06, 1997
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
K955816 · DYG
Baxter Healthcare Corp
Cardiovascular · 497d
Cleared May 06, 1997
AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM
K955622 · LHI
Baxter Healthcare Corp
General Hospital · 512d
Cleared May 05, 1997
MODIFIED USSC* POLYSORB SUTURE
K970863 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 56d
Cleared Apr 23, 1997
KENDALL HYDROPHILIC POWDER WOUND DRESSING
K970266 · KGN
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Apr 16, 1997
MODEL 1700 TRANQUILITY BILEVEL SYSTEM
K970173 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 90d
Cleared Apr 16, 1997
OPTIVENT
K963793 · CAF
Health Care Products, Inc.
Anesthesiology · 205d
Cleared Apr 15, 1997
COMPRESSOR/NEBULIZER #3650
K970289 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 81d
Cleared Apr 14, 1997
AMERIGEL OINTMENT
K970133 · MGQ
Amerx Health Care Corp.
General & Plastic Surgery · 89d