FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
174697–174720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1976
REAGENT SYSTEM
K760821 · CJT
Sigma Chemical Co.
Chemistry · 8d
Cleared Oct 21, 1976
MODEL TX-8 PANENDOSCOPE
K760822 · FAK
American Cystocope Makers, Inc.
Gastroenterology & Urology · 8d
Cleared Oct 20, 1976
BAG, LEG, URINE COLLECTING DEVICE
K760069 · KNX
Pharmaseal Div., Baxter Healthcare Corp.
Gastroenterology & Urology · 126d
Cleared Oct 20, 1976
BAG, DISPOSABLE URINARY LEG
K760260 · KNX
Intermed, Inc.
Gastroenterology & Urology · 92d
Cleared Oct 20, 1976
WHEEL'N WEIGH
K760327 · INF
Acme Medical Scale Co.
Physical Medicine · 85d
Cleared Oct 20, 1976
SHIRT, MITTEN CUFF INFANT
K760360 · FME
Precept, Inc.
General Hospital · 79d
Cleared Oct 20, 1976
CATHETER, NATURAL LATEX URETHRAL
K760440 · KOD
Akron Catheter, Inc.
Gastroenterology & Urology · 65d
Cleared Oct 20, 1976
CATHETER, PERITONEAL DIALYSIS
K760544 · FKO
Travenol Laboratories, S.A.
Gastroenterology & Urology · 51d
Cleared Oct 20, 1976
CUTTER JEL-ALGINATE IMPRESSION MAT.
K760753 · ELW
Cutter Laboratories, Inc.
Dental · 19d
Cleared Oct 20, 1976
COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I
K760763 · HEX
Dynatech Cryomedical Co.
Obstetrics & Gynecology · 16d
Cleared Oct 20, 1976
FIBER OPTICS HIGH SPEED HANDPIECE
K760794 · EFB
Midwest
Dental · 12d
Cleared Oct 20, 1976
FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C.
K760795 · EAY
Midwest
Dental · 12d
Cleared Oct 20, 1976
ORALUMINATOR III - LIGHT SOURCE FOR F.O.
K760796 · EAY
Midwest
Dental · 12d
Cleared Oct 20, 1976
PHYSIOLOGICAL MONITOR (MODEL 870)
K760803 · DRT
Datascope Corp.
Cardiovascular · 8d
Cleared Oct 20, 1976
ORTHOPEDIC TUBULAR STOCKINETTE
K760817 · ILG
Parke-Davis Co.
Physical Medicine · 8d
Cleared Oct 20, 1976
NALGENE EMERGENCY EYE WASH
K760820 · KYG
Nagle Co.
Ophthalmic · 7d
Cleared Oct 20, 1976
GEOMEDIC ANAMETRIC TOTAL KNEE
K760842 · HRY
Howmedica Corp.
Orthopedic · 6d
Cleared Oct 15, 1976
ELECTRODE, CUTTING LOOP
K760178 · KNS
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 101d
Cleared Oct 15, 1976
DIALYZER, HF 130 HOLLOW FIBER
K760252 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 88d
Cleared Oct 15, 1976
ELECTRODE, TEMPORARY MYOCARDIAL
K760513 · DTB
Winn Hirsch & Assoc.
Cardiovascular · 51d
Cleared Oct 15, 1976
PREFILLED HUMIDIFIER
K760566 · BTT
Foregger Air Products & Chem., Inc.
Anesthesiology · 43d
Cleared Oct 15, 1976
U-MID PREFILLED HUMIDIFIER (500CC)
K760584 · BTT
Bd Becton Dickinson Vacutainer...
Anesthesiology · 42d
Cleared Oct 15, 1976
U-MID PREFILLED NEBULIZER
K760585 · CAF
Bd Becton Dickinson Vacutainer...
Anesthesiology · 42d
Cleared Oct 15, 1976
U-MID PREFILLED HUMIDIFIER (300CC)
K760587 · BTT
Bd Becton Dickinson Vacutainer...
Anesthesiology · 42d