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
77353–77376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2001
C. NET 2100
K010396 · MLO
Cardionetics, Ltd.
Cardiovascular · 237d
Cleared Oct 04, 2001
AL-40
K010715 · GEX
Ddc Technologies, Inc.
General & Plastic Surgery · 209d
Cleared Oct 04, 2001
MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS
K010804 · GEX
Biolitec, Inc.
General & Plastic Surgery · 202d
Cleared Oct 04, 2001
PULSEMASTER ERBIUM DENTAL LASER SYSTEM
K012127 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Oct 04, 2001
THE QUIET SLEEPER
K012142 · LRK
Precision Dental Laboratories, Inc.
Dental · 86d
Cleared Oct 04, 2001
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL...
K012235 · KPM
Denver Biomedical, Inc.
Gastroenterology & Urology · 79d
Cleared Oct 04, 2001
THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
K012525 · LCP
Thermo Dma, Inc.
Chemistry · 59d
Cleared Oct 04, 2001
DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
K012710 · LYZ
Shijiazhuang Brilliance Plastic Co.,...
General Hospital · 51d
Cleared Oct 04, 2001
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
K012923 · GAT
Arthrex, Inc.
General & Plastic Surgery · 34d
Cleared Oct 04, 2001
URETEX SUP PUBOURETHRAL SLING
K012949 · OTN
Sofradim Production
Gastroenterology & Urology · 30d
Cleared Oct 04, 2001
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K012950 · DXT
Medrad, Inc.
Cardiovascular · 30d
Cleared Oct 04, 2001
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING...
K012967 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Oct 04, 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 04, 2001
MODIFICATION TO: THERMACOOL IIA
K013034 · GEI
Thermage, Inc.
General & Plastic Surgery · 24d
Cleared Oct 03, 2001
MEDCOMP EXCELL SPLIT TIP CATHETER
K010306 · MSD
Medcomp
Gastroenterology & Urology · 244d
Cleared Oct 03, 2001
PRO-FEMUR
K012091 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Oct 03, 2001
THE SALICEPT ORAL PATCH
K012126 · OLR
Carrington Laboratories, Inc.
General & Plastic Surgery · 89d
Cleared Oct 03, 2001
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
K012336 · DSI
Medical Data Electronics
Cardiovascular · 71d
Cleared Oct 03, 2001
NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
K012345 · IPL
Bromac Assistive Technology
Physical Medicine · 71d
Cleared Oct 03, 2001
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
K012446 · BSZ
Charles A. Smith
Anesthesiology · 63d
Cleared Oct 03, 2001
ATAC PAK CPK REAGENT KIT
K012474 · CGS
Elan Holdings, Inc.
Chemistry · 62d
Cleared Oct 03, 2001
EASYTRAVEL
K012592 · INI
Tzora Active Systems , Ltd.
Physical Medicine · 54d
Cleared Oct 03, 2001
MODIFICATION TO VAXCEL DIALYSIS CATHETER
K012948 · MSD
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 29d
Cleared Oct 03, 2001
BIPOLAR IRRIGATION FORCEPS
K012986 · GEI
Aesculap, Inc.
General & Plastic Surgery · 27d