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
118033–118056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1992
MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE
K914874 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 112d
Cleared Feb 18, 1992
AM 300 XP
K914947 · ESD
Electone, Inc.
Ear, Nose, Throat · 106d
Cleared Feb 18, 1992
A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES
K915300 · GEI
Alto Development Corp.
General & Plastic Surgery · 89d
Cleared Feb 18, 1992
MODEL 795 FLUOROMETER/DENSITOMETER
K915332 · JQT
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Feb 18, 1992
MICROPROTEIN-PR
K915380 · CEK
Sigma Diagnostics, Inc.
Chemistry · 81d
Cleared Feb 18, 1992
EMIT D.A.U BENZODIAZEPINE ASSAY
K915501 · JXM
Syva Co.
Toxicology · 71d
Cleared Feb 18, 1992
3D PROCESSING OPTIONS FOR GYREX
K915579 · LNH
Elscint, Inc.
Radiology · 67d
Cleared Feb 18, 1992
LIPASE REAGENT SET
K915706 · CET
Tech Intl. Co.
Chemistry · 81d
Cleared Feb 18, 1992
ANGEION ENDOSCOPIC VALVE SEAL
K915719 · ODC
Angeion Corp.
Gastroenterology & Urology · 60d
Cleared Feb 18, 1992
MODEL 6984M LEAD EXTENDER KIT
K915724 · DTD
Medtronic Vascular
Cardiovascular · 60d
Cleared Feb 18, 1992
IMX ESTRADIOL
K920047 · CHP
Abbott Laboratories
Chemistry · 43d
Cleared Feb 18, 1992
ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.
K920184 · GIM
Mbo Laboratories, Inc.
Hematology · 34d
Cleared Feb 18, 1992
AFFINITY PRG
K920230 · JLS
Bd Becton Dickinson Vacutainer...
Chemistry · 32d
Cleared Feb 18, 1992
MINI VIBRATOR
K920487 · IRO
Alimed, Inc.
Physical Medicine · 19d
Cleared Feb 14, 1992
DANEK SPINALSCOPE
K901692 · HRX
Danek Medical, Inc.
Orthopedic · 674d
Cleared Feb 14, 1992
PTI ANNULOPLASTY RING(STERILE)
K905175 · KRH
Pioneering Technologies, Inc.
Cardiovascular · 452d
Cleared Feb 14, 1992
RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM
K911835 · DSI
Gs Microsystems
Cardiovascular · 295d
Cleared Feb 14, 1992
LIKEPAK 11 CARDIAC MONIT/LIFENET RS100 REC STATION
K912189 · LOS
Physio-Control Corp.
Cardiovascular · 273d
Cleared Feb 14, 1992
3100 INFUSION PUMP
K912192 · FRN
Graseby Medical , Ltd.
General Hospital · 273d
Cleared Feb 14, 1992
3000 INFUSION PUMP
K912193 · FRN
Graseby Medical , Ltd.
General Hospital · 273d
Cleared Feb 14, 1992
ELECTRODE
K912643 · GXY
Skylark Device Co., Ltd.
Neurology · 245d
Cleared Feb 14, 1992
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
K912666 · LIQ
Dako Corp.
Microbiology · 241d
Cleared Feb 14, 1992
ACACIAS PHARM/PUMP
K912771 · LHI
Acacia, Inc.
General Hospital · 235d
Cleared Feb 14, 1992
SOF-FLEX LAPAROSCOPIC BASKET
K913299 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 204d