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"
3553–3576 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 09, 1997
3M RED DOT 2560 & 2570 MONITORING ELECTRODES
K970796 · DRX
3M Healthcare
Cardiovascular · 36d
Cleared Apr 03, 1997
KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
K970399 · IMD
Allegiance Healthcare Corp.
Physical Medicine · 59d
Cleared Apr 02, 1997
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
K970438 · FPA
Baxter Healthcare Corp
General Hospital · 56d
Cleared Mar 31, 1997
INTRAVIA CONTAINER, EMPTY
K964853 · KPE
Baxter Healthcare Corp
General Hospital · 118d
Cleared Mar 27, 1997
CONVERTORS IMPERVIOUS SHOE COVERS
K970815 · FXP
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Mar 25, 1997
FIXATION PIN OR ROD
K970036 · HTY
United States Surgical, A Division of...
Orthopedic · 81d
Cleared Mar 25, 1997
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
K963203 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 222d
Cleared Mar 18, 1997
KENDALL DUAL LUMEN CATHETER
K963446 · MPB
Kendall Healthcare Products Co....
Gastroenterology & Urology · 196d
Cleared Mar 17, 1997
EMERGENCY RELIEF KIT SYSTEM
K964029 · LRR
Baxter Healthcare Corp
General & Plastic Surgery · 161d
Cleared Mar 12, 1997
INTEGRATED VISUALIZATION SYSTEM
K970598 · FCW
Urohealth, Inc.
Gastroenterology & Urology · 22d
Cleared Mar 11, 1997
PREPOWDERED LATEX EXAMINATION GLOVE
K970313 · LYY
Besglove Healthcare Sdn. Bhd.
General Hospital · 43d
Cleared Mar 11, 1997
ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES
K964474 · KGO
Allegiance Healthcare Corp.
General Hospital · 124d
Cleared Feb 25, 1997
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850 · FPA
Baxter Healthcare Corp
General Hospital · 84d
Cleared Feb 25, 1997
RESPIFLO
K962872 · CAF
Tyco Healthcare Deutschaland GmbH
Anesthesiology · 217d
Cleared Feb 24, 1997
HI-STAR MRI IMAGING SYSTEM
K964778 · LNH
Health Images, Inc.
Radiology · 89d
Cleared Feb 20, 1997
MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
K962517 · MNS
Healthdyne Technologies, Inc.
Anesthesiology · 238d
Cleared Feb 12, 1997
TROCAR CANNULA
K963115 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 184d
Cleared Feb 11, 1997
AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION
K964697 · DXN
Advance Medical Device, Inc.
Cardiovascular · 81d
Cleared Feb 07, 1997
KENDALL CURITY URETERAL CATHETER
K964899 · EYB
Kendall Healthcare Products Co....
Gastroenterology & Urology · 66d
Cleared Feb 07, 1997
RIGID FIBER OPTIC LAPAROSCOPE
K962246 · HET
Health Care International Assoc.
Obstetrics & Gynecology · 241d
Cleared Jan 16, 1997
SOFSILK
K964581 · GAP
United States Surgical, A Division of...
General & Plastic Surgery · 62d
Cleared Jan 07, 1997
CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
K962978 · DYB
Johnson & Johnson Medical, Inc.
Cardiovascular · 160d
Cleared Dec 31, 1996
ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
K964515 · FNL
M.C. Healthcare Products, Inc.
General Hospital · 76d
Cleared Dec 31, 1996
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
K964127 · GCX
Allegiance Healthcare Corp.
General Hospital · 77d