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
167233–167256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1980
ECHO-OCULOMETER #3000
K791766 · IYO
Jedmed Instrument Co.
Radiology · 162d
Cleared Feb 19, 1980
UVB LIGHT BOX - UVB LIGHT BOOTH
K792500 · FTC
Sun Shanty, Inc.
General & Plastic Surgery · 77d
Cleared Feb 19, 1980
TREADMILL MODEL 3060
K792661 · IOL
Cambridge Instruments, Inc.
Physical Medicine · 55d
Cleared Feb 19, 1980
HUESTIS FLEXI-HOLDER
K792721 · IXA
Huestis Machine Corp.
Radiology · 50d
Cleared Feb 19, 1980
FUSON BONE PLUG, RADIOPAQUE
K800142 · JDS
Zimmer, Inc.
Orthopedic · 29d
Cleared Feb 19, 1980
DYNAMIC EXTENSOR SPLINT
K800143 · ILH
Biomet, Inc.
Physical Medicine · 29d
Cleared Feb 19, 1980
FEMORAL CEMENT RESTRICTOR
K800144 · JDS
Biomet, Inc.
Orthopedic · 29d
Cleared Feb 19, 1980
SURGIKOS NEUTRALON BR. SURGEON'S GLOVE
K800152 · KGO
Surgikos, Inc.
General Hospital · 28d
Cleared Feb 19, 1980
IMMUNOGLOBULIN A REAGENT SYSTEM
K800211 · CZP
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Feb 19, 1980
COMPLEMENT C3 REAGENT SYSTEM
K800212 · CZW
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Feb 19, 1980
SURGITEK FOERSTER FACE LIFT BANDAGE
K800248 · FRL
Medical Engineering Corp.
General Hospital · 13d
Cleared Feb 19, 1980
SURGITEK FOERSTER MAMMARY BANDAGE
K800249 · FRL
Medical Engineering Corp.
General Hospital · 13d
Cleared Feb 19, 1980
ACUFEX FORCEPS
K800273 · HTD
Acufex Microsurgical, Inc.
General & Plastic Surgery · 12d
Cleared Feb 19, 1980
ACUFEX PROBES
K800274 · HXB
Acufex Microsurgical, Inc.
Orthopedic · 12d
Cleared Feb 19, 1980
CEBOTOME DRILL
K800275 · HSZ
American Sterilizer Co.
Orthopedic · 12d
Cleared Feb 19, 1980
ENDEX REAMERS PULP CANAL, ENDODONTIC
K800291 · EKP
Ipco Corp.
Dental · 8d
Cleared Feb 19, 1980
ENDEX BROACH, ENDODONTIC
K800292 · EKW
Ipco Corp.
Dental · 8d
Cleared Feb 19, 1980
FILE, PULP CANAL
K800293 · EKS
Ipco Corp.
Dental · 8d
Cleared Feb 13, 1980
IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-
K792373 · DXK
Ipco Corp.
Cardiovascular · 79d
Cleared Feb 13, 1980
CALBIOCHEM-BEHRING RIA-COUNT
K792460 · CDD
Calbiochem-Behring Corp.
Chemistry · 72d
Cleared Feb 13, 1980
WHOLE BLOOD PLATELET CONTROL NORMAL,
K792606 · JPK
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 57d
Cleared Feb 13, 1980
MICROMEDIC PUNCH & ELUTER
K800075 · JQW
Micromedic Systems
Chemistry · 30d
Cleared Feb 13, 1980
SYSTEM 203 CHEMISTRY ANALYZER
K800085 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 30d
Cleared Feb 13, 1980
LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
K800106 · CEP
Radioimmunoassay, Inc.
Chemistry · 28d