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
85201–85224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1999
NASO-LARYNGO-PHARYNGOSCOPE
K991560 · EOB
Fiber Imaging Technologies, Inc.
Ear, Nose, Throat · 70d
Cleared Jul 13, 1999
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
K991733 · MRR
Schiapparelli Biosystems, Inc.
Chemistry · 53d
Cleared Jul 13, 1999
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
K991992 · KGO
Allegiance Healthcare Corp.
General Hospital · 29d
Cleared Jul 13, 1999
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
K992163 · DOP
Pdz-Europa , Ltd.
Toxicology · 18d
Cleared Jul 13, 1999
AT HOME DRUG TEST, MODEL 9175
K992217 · MVO
Phamatech
Toxicology · 12d
Cleared Jul 12, 1999
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 375d
Cleared Jul 12, 1999
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
K982943 · NFB
Transtracheal Systems
Anesthesiology · 325d
Cleared Jul 12, 1999
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
K983203 · GGT
Diagnostic Products Corp.
Hematology · 301d
Cleared Jul 12, 1999
NITRILON CORRECT-TOUCH
K984512 · KGO
Ct Intl.
General Hospital · 206d
Cleared Jul 12, 1999
THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER
K984639 · ITX
Medison America, Inc.
Radiology · 193d
Cleared Jul 12, 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
K990135 · LPH
Zimmer, Inc.
Orthopedic · 180d
Cleared Jul 12, 1999
TROCAR SYSTEM ACCORDING TO HASSON
K990237 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 169d
Cleared Jul 12, 1999
EARLOOP FACE MASK
K990719 · FXX
Shuenn Bao Shing Corp.
General Hospital · 129d
Cleared Jul 12, 1999
SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS...
K991267 · HAW
Ohio Medical Instrument Co., Inc.
Neurology · 90d
Cleared Jul 12, 1999
CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2,...
K991272 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 90d
Cleared Jul 12, 1999
PASS/FAIL CHALLENGE PACK
K991276 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 89d
Cleared Jul 12, 1999
LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE
K991285 · GEX
Aesculap-Meditec North America
General & Plastic Surgery · 88d
Cleared Jul 12, 1999
UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES
K991297 · GEX
Medart Corp.
General & Plastic Surgery · 88d
Cleared Jul 12, 1999
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
K991300 · BWF
Dhd Healthcare Corp.
Anesthesiology · 87d
Cleared Jul 12, 1999
VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
K991303 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Jul 12, 1999
BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY
K991336 · IYE
Medical Instrumentation & Diagnostics...
Radiology · 84d
Cleared Jul 12, 1999
OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER
K991377 · GCJ
Omnisonics Medical Technologies
General & Plastic Surgery · 82d
Cleared Jul 12, 1999
PARIETENE POLYPROPYLENE MESH
K991400 · FTL
Sofradim Production
General & Plastic Surgery · 81d
Cleared Jul 12, 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485 · LPH
Smith & Nephew, Inc.
Orthopedic · 75d