FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
85705–85728 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1999
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
K991567 · FTM
Shelhigh, Inc.
General & Plastic Surgery · 70d
Cleared Jul 14, 1999
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING...
K991616 · LYY
Hartalega Sdn Bhd
General Hospital · 65d
Cleared Jul 14, 1999
26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER
K991622 · JDI
Stelkast Company
Orthopedic · 64d
Cleared Jul 14, 1999
DEPUY ROCKWOOD CLAVICLE PIN
K991649 · JDW
Depuy, Inc.
Orthopedic · 62d
Cleared Jul 14, 1999
COBREX HIP STEM, MODEL 01-128-XXXXX
K991869 · JDI
Implex Corp.
Orthopedic · 43d
Cleared Jul 14, 1999
REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
K992151 · LAS
Consolidated Technologies, Inc.
Toxicology · 20d
Cleared Jul 13, 1999
ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
K972772 · MJA
Trek Diagnostic Systems, Inc.
Microbiology · 719d
Cleared Jul 13, 1999
SCLERAL PLUGS, 19 AND 20 GAUGE
K990872 · LXP
Ophthalmic Consultants, Inc.
Ophthalmic · 119d
Cleared Jul 13, 1999
AHMED GLAUCOMA VALVE IMPLANT
K991072 · KYF
New World Medical, Inc.
Ophthalmic · 104d
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