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"
4273–4296 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 09, 1991
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
K912554 · KRH
Baxter Healthcare Corp
Cardiovascular · 90d
Cleared Sep 04, 1991
DRY TIME
K911279 · KPN
Health Sense Intl., Inc.
Gastroenterology & Urology · 163d
Cleared Aug 29, 1991
STERILE SURGICAL PACK
K904873 · KKX
Angelica Healthcare Services
General Hospital · 303d
Cleared Aug 26, 1991
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV
K910921 · HET
United States Surgical, A Division of...
Obstetrics & Gynecology · 174d
Cleared Aug 22, 1991
MONARCH SYSTEM
K911051 · MHX
Baxter Healthcare Corp
Cardiovascular · 167d
Cleared Aug 20, 1991
SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION
K912078 · DTZ
3M Health Care, Sarns
Cardiovascular · 102d
Cleared Aug 16, 1991
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K913236 · DHA
Baxter Healthcare Corp
Toxicology · 25d
Cleared Aug 16, 1991
H.I.STANDARD CALIBRE UPGRADE
K911746 · LNH
Health Images, Inc.
Radiology · 120d
Cleared Aug 13, 1991
TOPS NEEDLE TIP PROBE & PVC TIP PROBE
K910453 · CCE
Baxter Healthcare Corp
Anesthesiology · 193d
Cleared Aug 12, 1991
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL
K912455 · JJY
Baxter Healthcare Corp
Chemistry · 70d
Cleared Aug 12, 1991
DUNLAP HEAT PAD
K911195 · IRT
Home Healthcare Products, Inc.
Physical Medicine · 147d
Cleared Aug 09, 1991
INSIDE JOB
K912871 · HRX
3M Health Care, Ltd.
Orthopedic · 42d
Cleared Aug 09, 1991
JEJUNO-CATH KIT
K905677 · FPD
Health Improvement Assoc.
Gastroenterology & Urology · 233d
Cleared Aug 07, 1991
SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION
K911105 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 148d
Cleared Jul 31, 1991
DEVILBISS MODEL 5000
K911896 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 96d
Cleared Jul 26, 1991
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
K912520 · KGX
3M Health Care, Ltd.
General & Plastic Surgery · 50d
Cleared Jul 24, 1991
OPTYX
K904883 · JXG
Baxter Healthcare Corp
Neurology · 271d
Cleared Jul 23, 1991
PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS
K912542 · KKX
Puritas Health Care, Inc.
General Hospital · 43d
Cleared Jul 22, 1991
PULSATILE ANTI-EMBOLISM SYS.PUMP
K911853 · JOW
Baxter Healthcare Corp
Cardiovascular · 87d
Cleared Jul 12, 1991
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
K905778 · FRN
Baxter Healthcare Corp
General Hospital · 197d
Cleared Jul 11, 1991
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429 · DXO
Baxter Healthcare Corp
Cardiovascular · 160d
Cleared Jul 09, 1991
BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
K911606 · KDD
Baxter Healthcare Corp
General & Plastic Surgery · 90d
Cleared Jun 24, 1991
INTERLINK(TM) BLUNT CANNULA, MODIFICATION
K911868 · FPA
Baxter Healthcare Corp
General Hospital · 59d
Cleared Jun 24, 1991
FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
K910934 · FRN
Baxter Healthcare Corp
General Hospital · 110d