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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73393–73416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2002
BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
K022643 · MQH
Swemed Lab International AB
Obstetrics & Gynecology · 89d
Cleared Nov 05, 2002
CURAD
K022645 · KMF
Beiersdorf AG
General & Plastic Surgery · 89d
Cleared Nov 05, 2002
RANDOX C-REACTIVE PROTEIN CALIBRATOR
K022682 · JIS
Randox Laboratories, Ltd.
Chemistry · 85d
Cleared Nov 05, 2002
INSTANT-VIEW LH OVULATION PREDICTING TEST
K022829 · CEP
Alfa Scientific Designs, Inc.
Chemistry · 71d
Cleared Nov 05, 2002
PROMOTOR
K023106 · MQL
Ceres Fertility, Inc.
Obstetrics & Gynecology · 48d
Cleared Nov 05, 2002
CERANUM 82
K023197 · EJT
Sb Lucius, Inc.
Dental · 41d
Cleared Nov 05, 2002
EXTRA LARGE BODY COIL
K023442 · MOS
GE Medical Systems
Radiology · 21d
Cleared Nov 05, 2002
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
K023511 · LNH
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Nov 05, 2002
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
K023586 · MQB
Canon USA, Inc.
Radiology · 11d
Cleared Nov 04, 2002
AUTOCON II 400 ELECTROSURGICAL GENERATOR
K021467 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 181d
Cleared Nov 04, 2002
MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
K021576 · CCK
Mercury Medical
Anesthesiology · 174d
Cleared Nov 04, 2002
DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION
K021732 · KDI
Dideco S.P.A.
Gastroenterology & Urology · 164d
Cleared Nov 04, 2002
LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K022007 · MOS
Usa Instruments, Inc.
Radiology · 138d
Cleared Nov 04, 2002
PHLEBOTEST 2000
K022047 · JOM
Osborn Medical Corp.
Cardiovascular · 133d
Cleared Nov 04, 2002
REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
K022751 · KGE
Medical Device Services
Gastroenterology & Urology · 77d
Cleared Nov 04, 2002
HYALURONIDASE SOLUTION
K022931 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 61d
Cleared Nov 04, 2002
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
K022948 · HIB
Medical Action Industries, Inc.
Obstetrics & Gynecology · 60d
Cleared Nov 04, 2002
CERANUM 50
K023199 · EJT
Sb Lucius, Inc.
Dental · 40d
Cleared Nov 04, 2002
CERANUM 76
K023200 · EJT
Sb Lucius, Inc.
Dental · 40d
Cleared Nov 04, 2002
HEMCON BANDAGE
K023298 · QSY
Hemcon, Inc.
General & Plastic Surgery · 32d
Cleared Nov 04, 2002
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · KKX
Medline Industries, Inc.
General Hospital · 20d
Cleared Nov 04, 2002
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
K023497 · MSX
Datex-Ohmeda
Cardiovascular · 17d
Cleared Nov 04, 2002
SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS
K023569 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 11d
Cleared Nov 04, 2002
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
K023616 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 6d