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"
3721–3744 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 10, 1995
AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM**
K952748 · LJT
United States Surgical, A Division of...
General Hospital · 55d
Cleared Aug 09, 1995
ACU-HALT
K945374 · LDQ
Eva-Health USA, Inc.
General & Plastic Surgery · 280d
Cleared Aug 07, 1995
HOMEVUE WOUND MONITORING SYSTEM
K945807 · LLZ
Homevue Health Systems, Inc.
Radiology · 252d
Cleared Aug 04, 1995
V. MUELLER OBSTETRICAL (OB) FORCEPS
K951529 · HDA
Baxter Healthcare Corp
Obstetrics & Gynecology · 123d
Cleared Jul 27, 1995
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
K952074 · FPA
Baxter Healthcare Corp
General Hospital · 86d
Cleared Jul 26, 1995
DOPPLEX SURGICAL PROBES
K946300 · ITX
Hne Healthcare, Inc.
Radiology · 210d
Cleared Jul 26, 1995
BIO-COR COLLAGEN CORNEAL SHIELD
K944872 · MOE
Bausch & Lomb Healthcare and Optics...
Ophthalmic · 296d
Cleared Jul 25, 1995
WHITE KNIGHT SURGEON'S VEST
K951984 · FYA
White Knight Healthcare
General Hospital · 89d
Cleared Jul 21, 1995
AQUAGEL LUBRICATING JELLY
K951431 · KMJ
Depuy Healthcare
General Hospital · 116d
Cleared Jul 20, 1995
TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES
K952786 · LYZ
Baxter Healthcare Corp
General Hospital · 31d
Cleared Jul 20, 1995
HEALTH IMAGES, INC. HI-STANDARD
K944228 · LNH
Health Images, Inc.
Radiology · 323d
Cleared Jul 10, 1995
AUTO SYRINGE(R) AS50 INFUSION PUMP
K945942 · FRN
Baxter Healthcare Corp
General Hospital · 217d
Cleared Jul 06, 1995
THORACENTESIS CATHETER
K951524 · JOL
Baxter Healthcare Corp
General Hospital · 94d
Cleared Jun 29, 1995
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
K944007 · EZL
Baxter Healthcare Corp
Gastroenterology & Urology · 317d
Cleared Jun 22, 1995
BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES
K951307 · DQX
Baxter Healthcare Corp
Cardiovascular · 92d
Cleared Jun 19, 1995
LEGEND
K952441 · INQ
Health Care Mfg., Inc.
Physical Medicine · 25d
Cleared Jun 16, 1995
AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI
K932985 · HIS
Sime Health, Ltd.
Obstetrics & Gynecology · 728d
Cleared Jun 14, 1995
HCI TUBE STABILIZER
K942529 · CBH
Health Care Contracts, Inc.
Anesthesiology · 383d
Cleared Jun 07, 1995
VH-2000
K951323 · INQ
Health Care Mfg., Inc.
Physical Medicine · 76d
Cleared Jun 05, 1995
NH-2002
K932050 · QJQ
New Horizon Health Care
Neurology · 769d
Cleared Jun 01, 1995
HLT 406
K951382 · INQ
Health Care Mfg., Inc.
Physical Medicine · 66d
Cleared May 26, 1995
ATT-300
K944699 · ITH
Health Care Mfg., Inc.
Physical Medicine · 245d
Cleared May 24, 1995
REMOTE A'LERT
K943559 · KPN
Health Sense Intl., Inc.
Gastroenterology & Urology · 306d
Cleared May 24, 1995
PRO'TECT
K943558 · KPN
Health Sense Intl., Inc.
Gastroenterology & Urology · 306d