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"
4297–4320 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 21, 1991
4.5F IMAGECATH ANGIOSCOPE
K905083 · LYK
Baxter Healthcare Corp
Cardiovascular · 220d
Cleared Jun 20, 1991
STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
K912241 · JLW
Baxter Healthcare Corp
Chemistry · 30d
Cleared Jun 11, 1991
DADE(R) PROTEIN C ABNORMAL CONTRAL
K911885 · GGC
Baxter Healthcare Corp
Hematology · 43d
Cleared Jun 10, 1991
DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL
K911854 · JJY
Baxter Healthcare Corp
Chemistry · 45d
Cleared Jun 10, 1991
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
K911367 · DQO
Baxter Healthcare Corp
Cardiovascular · 74d
Cleared Jun 10, 1991
ULTRASET CATHETER
K911294 · BZA
Dhd Diemolding Healthcare Div.
Anesthesiology · 77d
Cleared Jun 03, 1991
DASH MEDICAL GLOVES
K912038 · LYY
Safehealth Labs
General Hospital · 26d
Cleared May 31, 1991
VOLUMETRIC INFUSION PUMP
K910024 · FRN
Baxter Healthcare Corp
General Hospital · 148d
Cleared May 29, 1991
NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS
K911227 · DTZ
3M Health Care, Sarns
Cardiovascular · 70d
Cleared May 29, 1991
HYPERGEL PROTECTIVE WOUND GEL
K905439 · KMF
Scott Health Care
General & Plastic Surgery · 176d
Cleared May 28, 1991
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
K911106 · KOC
Baxter Healthcare Corp
Gastroenterology & Urology · 77d
Cleared May 28, 1991
3M 6830 ELECTRODE
K905539 · GXY
3M Healthcare
Neurology · 168d
Cleared May 21, 1991
EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP
K911289 · FRN
Baxter Healthcare Corp
General Hospital · 57d
Cleared May 17, 1991
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K910791 · BSP
Kendall Healthcare Products Co....
Anesthesiology · 81d
Cleared May 15, 1991
STRATUS(R) AUTOMATED SAMPLE HANDLER
K911712 · JQW
Baxter Healthcare Corp
Chemistry · 28d
Cleared May 06, 1991
MULTIPLE, SURGICAL DRAPE PACK
K911132 · FZI
Central Georgia Ancillary Health Systems
General & Plastic Surgery · 53d
Cleared May 01, 1991
SLEEPER MASK SYSTEM
K904344 · BZD
Devilbiss Health Care, Inc.
Anesthesiology · 219d
Cleared Apr 25, 1991
KENDALL PEDIATRIC URINE METER
K911258 · EXR
Kendall Healthcare Products Co....
Gastroenterology & Urology · 34d
Cleared Apr 25, 1991
KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER
K911242 · KOD
Kendall Healthcare Products Co....
Gastroenterology & Urology · 35d
Cleared Apr 24, 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
K910204 · DQO
Baxter Healthcare Corp
Cardiovascular · 98d
Cleared Apr 18, 1991
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
K910270 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 85d
Cleared Apr 12, 1991
ALLDRESS MULTI LAYERED WOUND DRESSING
K910857 · NAB
Scott Health Care
General & Plastic Surgery · 43d
Cleared Apr 10, 1991
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
K910107 · DTZ
Baxter Healthcare Corp
Cardiovascular · 90d
Cleared Apr 08, 1991
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
K910428 · FRN
Baxter Healthcare Corp
General Hospital · 67d