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
163201–163224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1981
N-TERMINAL HPTH BY RIA
K811418 · CEW
Immuno Nuclear Corp.
Chemistry · 36d
Cleared Jun 24, 1981
KALLESTAD R QUANTIPLATE ALT. PATHWAY T.
K811445 · DHL
Kallestad Laboratories, Inc.
Immunology · 33d
Cleared Jun 24, 1981
BACILLUS CEREUS SELECTIVE(AGAR&SUPP)
K811514 · JSI
Oxoid U.S.A., Inc.
Toxicology · 27d
Cleared Jun 24, 1981
THIOGLYCOLLATE MED. W/OUT INDICATOR
K811515 · JSG
Oxoid U.S.A., Inc.
Toxicology · 27d
Cleared Jun 24, 1981
LEGIONELLA, GROWTH & SELECTIVE, SUPP.
K811516 · JSK
Oxoid U.S.A., Inc.
Toxicology · 27d
Cleared Jun 24, 1981
VCN SUPPLEMENT
K811517 · JSK
Oxoid U.S.A., Inc.
Toxicology · 27d
Cleared Jun 24, 1981
VCNT ANTIBIOTIC SUPPLEMENT
K811518 · JSK
Oxoid U.S.A., Inc.
Toxicology · 27d
Cleared Jun 24, 1981
KALLESTAD QUANTITOPE LOW LEVEL IGE REAG
K811545 · DGC
Kallestad Laboratories, Inc.
Chemistry · 23d
Cleared Jun 23, 1981
AUTOMATED GASTRIC LAVAGE
K811061 · KNT
Emergency Medicine
Gastroenterology & Urology · 67d
Cleared Jun 23, 1981
X-CELL X-RAY #'S P-75W/P-75M
K811230 · KPR
X-Cel X-Ray Corp.
Radiology · 50d
Cleared Jun 23, 1981
CRYOPHTHALMIC UNIT
K811244 · HRS
Keeler Instruments, Inc.
Orthopedic · 50d
Cleared Jun 23, 1981
DIGITAL NOISE REDUCER
K811295 · JAA
Philips Medical Systems (Cleveland),...
Radiology · 43d
Cleared Jun 23, 1981
SOMATOM 2N
K811302 · IZF
Siemens Corp.
Radiology · 43d
Cleared Jun 23, 1981
MODEL DM-333 DIALYSIS CONTROL STATION
K811444 · FKQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 32d
Cleared Jun 23, 1981
MODEL RS-8100
K811457 · KOC
Rinal Systems, Inc.
Gastroenterology & Urology · 32d
Cleared Jun 23, 1981
MODEL FUS-1, FLEXIBLE URETEROSCOPE
K811535 · FGB
American Optical Corp.
Gastroenterology & Urology · 22d
Cleared Jun 23, 1981
CERVICAL SPATULA
K811548 · HHT
Procedure Products, Inc.
Obstetrics & Gynecology · 22d
Cleared Jun 19, 1981
7.5 MHZ WP TRANSDUCER
K810748 · ITX
General Electric Co.
Radiology · 91d
Cleared Jun 18, 1981
HEWLETT-PACKARD VENTILATOR
K810893 · CBK
Hewlett-Packard Co.
Anesthesiology · 77d
Cleared Jun 18, 1981
STRUVA & MEDI
K811173 · FQM
Weco
General Hospital · 51d
Cleared Jun 18, 1981
I.V. BOTTLE (RIDGID)
K811234 · KPE
Medi-Plast Intl., Inc.
General Hospital · 45d
Cleared Jun 18, 1981
QUINTON CATHETER FINGER GRIP
K811266 · FKO
Quinton, Inc.
Gastroenterology & Urology · 37d
Cleared Jun 18, 1981
BOTTLE-TO-BOTTLE
K811268 · KPE
Medi-Plast Intl., Inc.
General Hospital · 44d
Cleared Jun 18, 1981
POLAROID TPX RADIOGRAPHIC FILM
K811352 · IWZ
Polaroid Corp.
Radiology · 35d