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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
139945–139968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1987
SWANSON TITANIUM GREAT TOE IMPLANT
K864492 · KWD
Dow Corning Wright
Orthopedic · 153d
Cleared Apr 15, 1987
GRADTECH SYRINGE SYSTEM
K864732 · EGM
Gradtech
Dental · 132d
Cleared Apr 15, 1987
HICKMAN TITANIUM SUBCUTANEOUS PORT
K870260 · LJT
C.R. Bard, Inc.
General Hospital · 82d
Cleared Apr 15, 1987
CHROMAGEN TEST FOR GROUP A STREP
K870409 · JTO
Diversified Diagnostic Industries
Microbiology · 71d
Cleared Apr 15, 1987
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
K870519 · LJT
Norfolk Medical Products, Inc.
General Hospital · 68d
Cleared Apr 15, 1987
PROSTHESIS WIRE
K870766 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 48d
Cleared Apr 15, 1987
CUI NASAL SEPTUM BUTTON
K871200 · LFB
Cox-Uphuff Intl.
Ear, Nose, Throat · 21d
Cleared Apr 15, 1987
CYANMETHEMOGLOBIN STANDARD
K871283 · KRZ
U. S. Diagnostics, Inc.
Hematology · 15d
Cleared Apr 15, 1987
ORTHOPEDIC DRILL GUIDE
K871287 · HSZ
Orthopedic Systems, Inc.
Orthopedic · 15d
Cleared Apr 15, 1987
GDC 1830 CASTING ALLOY
K871288 · EJS
Deringer-Ney, Inc.
Dental · 15d
Cleared Apr 15, 1987
T.E.D.(TM) TRACTION DEVICE
K871296 · KQZ
The Kendal Co.
Orthopedic · 15d
Cleared Apr 15, 1987
FIBREFLEX
K871312 · EBI
Biomedical Composites, Ltd.
Dental · 14d
Cleared Apr 15, 1987
ORAL ASPIRATOR
K871315 · DYN
Endovations
Dental · 14d
Cleared Apr 15, 1987
DR FLOSSER REFILL
K871392 · JES
Flossrite Corp.
Dental · 8d
Cleared Apr 15, 1987
DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE
K871393 · JES
Flossrite Corp.
Dental · 8d
Cleared Apr 14, 1987
FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES
K863798 · LKQ
Whittaker Bioproducts, Inc.
Microbiology · 197d
Cleared Apr 14, 1987
RUBELLA MICROASSAY
K864602 · LFX
Diamedix Corp.
Microbiology · 141d
Cleared Apr 14, 1987
VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.
K870009 · DHB
Ventrex Laboratories, Inc.
Immunology · 102d
Cleared Apr 14, 1987
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
K870074 · JWY
Microscan Div. Baxter Healthcare Corp.
Microbiology · 96d
Cleared Apr 14, 1987
MODEL 5000 MICROMANIPULATOR MICRO CO2 LASER SYSTEM
K870161 · GEX
Coherent Medical Group
General & Plastic Surgery · 91d
Cleared Apr 14, 1987
PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY
K870420 · GBZ
North Coast Medi-Tek
General & Plastic Surgery · 70d
Cleared Apr 14, 1987
TETRATHIONATE BROTH
K870634 · KZI
Hardy Media
Microbiology · 60d
Cleared Apr 14, 1987
REGAN-LOWE MEDIUM
K870635 · JSJ
Hardy Media
Microbiology · 60d
Cleared Apr 14, 1987
HEMOPHILUS ID QUAD PLATE
K870636 · JSH
Hardy Media
Microbiology · 60d