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
116881–116904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1992
ULTRA PVD
K912925 · JAF
Advanced Medical Products, Inc.
Radiology · 351d
Cleared Jun 18, 1992
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR
K915694 · HIF
Medical Devices, Inc.
Obstetrics & Gynecology · 178d
Cleared Jun 18, 1992
BAIR HUGGER CUB BLANKET- SHORT MODEL 536
K920432 · DWJ
Augustine Medical, Inc.
Cardiovascular · 136d
Cleared Jun 18, 1992
VITA OMEGA PORCELAIN
K921474 · EIH
Vident
Dental · 80d
Cleared Jun 18, 1992
SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE
K921671 · GEX
Surgical Products Corp.
General & Plastic Surgery · 71d
Cleared Jun 18, 1992
ULTRALINE STERILE DISPOSABLE FIBER
K921807 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 64d
Cleared Jun 18, 1992
VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY
K921816 · JLW
Biomerieux Vitek, Inc.
Chemistry · 64d
Cleared Jun 17, 1992
DERMAGRAN WET DRESSING
K914746 · MGQ
Derma Sciences, Inc.
General & Plastic Surgery · 239d
Cleared Jun 17, 1992
HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES
K915086 · KGO
Hpi, Inc.
General Hospital · 218d
Cleared Jun 17, 1992
VJW2919 PNEUMATIC COMPRESSION UPGRADE
K920938 · IZH
Varian Canada, Inc.
Radiology · 111d
Cleared Jun 17, 1992
CATHETER MOUNTS -- MODIFICATION
K921511 · BZA
Intersurgical, Inc.
Anesthesiology · 85d
Cleared Jun 17, 1992
ENTENDED LINE ACCESSORIES & CONNECTORS
K921512 · BZA
Intersurgical, Inc.
Anesthesiology · 85d
Cleared Jun 17, 1992
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL
K921943 · LIT
Schneider Intl., Ltd.
Cardiovascular · 54d
Cleared Jun 16, 1992
POLARIS, GYNECOLOGY INDICATIONS
K912067 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 403d
Cleared Jun 16, 1992
MIL CM-II COAGULATION MACHINE
K913320 · GKN
Medical Innovations Corp.
Hematology · 327d
Cleared Jun 16, 1992
VERIMED PERINEOMETER
K913912 · HIR
Verimed Holdings, Inc.
Gastroenterology & Urology · 292d
Cleared Jun 16, 1992
IL TEST COMPLEMENT 3
K920007 · CZW
Instrumentation Laboratory CO
Immunology · 166d
Cleared Jun 16, 1992
IL TEST IMMUNOGLOBULIN A
K920014 · CZP
Instrumentation Laboratory CO
Immunology · 166d
Cleared Jun 16, 1992
PROLONGED OCCLUSION DRESSING II
K920874 · FRO
Ferndal Laboratories
General & Plastic Surgery · 111d
Cleared Jun 16, 1992
PROLONGED OCCLUSION DRESSING I
K920875 · FRO
Ferndal Laboratories
General & Plastic Surgery · 111d
Cleared Jun 16, 1992
CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE
K921147 · ITX
Cardiovascular Imaging Systems, Inc.
Radiology · 97d
Cleared Jun 16, 1992
CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE
K921148 · ITX
Cardiovascular Imaging Systems, Inc.
Radiology · 97d
Cleared Jun 16, 1992
ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE
K921601 · JES
Ultradent Products, Inc.
Dental · 74d
Cleared Jun 16, 1992
CEDIA RED BLOOD CELL FOLATE REAGENT PACK
K921689 · CGN
Microgenics Corp.
Chemistry · 69d