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
91561–91584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1997
OPUS HLH CONTROLS
K973832 · JJX
Behring Diagnostics, Inc.
Toxicology · 20d
Cleared Oct 24, 1997
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
K964398 · MGP
Polymedica Industries, Inc.
General & Plastic Surgery · 354d
Cleared Oct 24, 1997
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
K970595 · FEN
Circon Video
Gastroenterology & Urology · 248d
Cleared Oct 24, 1997
SMC ACETABULAR COMPONENT
K971018 · LPH
Signal Medical Corp.
Orthopedic · 218d
Cleared Oct 24, 1997
EVI SUTURED-CLIP APPLIER
K971588 · FZP
Elective Vascular Intervention Inc....
General & Plastic Surgery · 176d
Cleared Oct 24, 1997
AUTO SUTURE BONE WAX
K971680 · MTJ
United States Surgical, A Division of...
General & Plastic Surgery · 170d
Cleared Oct 24, 1997
DERMASCAN SURGICAL LASER SCANNER
K972028 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 144d
Cleared Oct 24, 1997
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND...
K972471 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 115d
Cleared Oct 24, 1997
PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
K972621 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 102d
Cleared Oct 24, 1997
HANSATOME MICROKERATOME
K972808 · HNO
Chiron Vision Corp.
Ophthalmic · 88d
Cleared Oct 24, 1997
CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
K972867 · ICX
Rocket Medical Plc
Pathology · 81d
Cleared Oct 24, 1997
TRI TALON RETRIEVAL FORCEPS
K973071 · OCZ
Medical Engineering Laboratory, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 24, 1997
TOTAL PERFORMANCE SYSTEM SHAVER
K973195 · HRX
Stryker Endoscopy
Orthopedic · 59d
Cleared Oct 24, 1997
HANAULUX BLUE 75 AND HANAULUX BLUE 120
K973466 · FSY
Heraeus Med GmbH
General & Plastic Surgery · 70d
Cleared Oct 24, 1997
DURALASTIC ANATOMICAL MALAR IMPLANT
K973574 · LZK
Hanson Medical, Inc.
General & Plastic Surgery · 35d
Cleared Oct 24, 1997
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · LHI
Baxter Healthcare Corp
General Hospital · 29d
Cleared Oct 23, 1997
BARIAIR
K955243 · FNM
Kinetic Concepts, Inc.
General Hospital · 708d
Cleared Oct 23, 1997
EDEMA SYSTEM
K962783 · DSB
Bioanalogics, Inc.
Cardiovascular · 463d
Cleared Oct 23, 1997
VIKING DIAGNOSTIC ELECTRODE CATHETER
K971265 · DRF
C.R. Bard, Inc.
Cardiovascular · 202d
Cleared Oct 23, 1997
MCD-AC
K971980 · KPS
Adac Laboratories
Radiology · 147d
Cleared Oct 23, 1997
BANG POLYMER GEL DOSIMETER, BANG 533
K972804 · IYE
Mgs Research, Inc.
Radiology · 87d
Cleared Oct 22, 1997
TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
K970742 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 236d
Cleared Oct 22, 1997
AHCS HEMOPERFUSION SYSTEM
K971015 · FLD
American Health Care Systems, Inc.
Gastroenterology & Urology · 216d
Cleared Oct 22, 1997
MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS...
K971420 · HIH
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 188d