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"
3649–3672 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Dec 26, 1996
ALBA HEALTH PAS WRAP SYSTEM
K961405 · JOW
Alba-Waldensian, Inc.
Cardiovascular · 259d
Cleared Dec 23, 1996
CONVERTORS DRAPE MATERIAL
K964125 · KKX
Allegiance Healthcare Corp.
General Hospital · 69d
Cleared Dec 20, 1996
CURITY THORACENTESIS TRAY
K964519 · GCX
Kendall Healthcare Products Co....
General Hospital · 38d
Cleared Dec 20, 1996
AUTO SUTURE* ABBI* SYSTEM
K963825 · KNW
United States Surgical, A Division of...
Gastroenterology & Urology · 87d
Cleared Nov 27, 1996
AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
K963999 · OCW
United States Surgical, A Division of...
Gastroenterology & Urology · 51d
Cleared Nov 27, 1996
HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3
K962195 · IRT
Sunbeam Health Division
Physical Medicine · 173d
Cleared Nov 25, 1996
HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4
K962252 · IRT
Sunbeam Health Division
Physical Medicine · 166d
Cleared Nov 22, 1996
UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)
K963211 · LYY
American Healthcare Products, Inc.
General Hospital · 98d
Cleared Nov 14, 1996
KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT
K961740 · LLZ
Kodak Health Imaging Systems, Inc.
Radiology · 195d
Cleared Nov 14, 1996
KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT
K961739 · LLZ
Kodak Health Imaging Systems, Inc.
Radiology · 195d
Cleared Nov 08, 1996
MMG MULTI LUMON EXTENSION SET
K963112 · FPA
Mmg Healthcare, Inc.
General Hospital · 88d
Cleared Oct 28, 1996
CONVERTORS POLYOLEFIN FABRIC GOWNS
K961341 · FYA
Baxter Healthcare Corp
General Hospital · 203d
Cleared Oct 25, 1996
PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
K962924 · BZH
Healthscan Products, Inc.
Anesthesiology · 88d