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
145153–145176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1986
FYODOROV RADIAL KERATOTOMY MARKER SET
K860329 · HHR
Med-Tech Develoment Corp.
Obstetrics & Gynecology · 14d
Cleared Feb 12, 1986
MAKLAKOV STYLE TONOMETER
K860330 · HKY
Med-Tech Develoment Corp.
Ophthalmic · 14d
Cleared Feb 12, 1986
DISPOSABLE SURGICAL KNIFE
K860331 · HNN
Med-Tech Develoment Corp.
Ophthalmic · 14d
Cleared Feb 12, 1986
SUNLAMP MODELS 24N, 30R, 30RE, 37RE
K860347 · FTC
Gti, Inc.
General & Plastic Surgery · 14d
Cleared Feb 12, 1986
CHEMO-VENT
K860434 · LHI
Intl. Medical Industries
General Hospital · 8d
Cleared Feb 12, 1986
IVAC MODEL 2080 ELECTRONIC THERMOMETER
K860436 · FLL
Y
General Hospital · 8d
Cleared Feb 11, 1986
PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG
K854469 · GEX
Minnesota Laser Corp.
General & Plastic Surgery · 97d
Cleared Feb 11, 1986
PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG
K854472 · GEX
Minnesota Laser Corp.
General & Plastic Surgery · 97d
Cleared Feb 11, 1986
S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER
K854669 · LNK
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 82d
Cleared Feb 11, 1986
MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM
K854770 · KWP
Advanced Biosearch Assn.
Orthopedic · 76d
Cleared Feb 11, 1986
NELSON-JUNG PLEURAL CATH
K854812 · GBW
Research Medical, Inc.
General & Plastic Surgery · 70d
Cleared Feb 11, 1986
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
K854945 · CDD
Ciba Corning Diagnostics Corp.
Hematology · 63d
Cleared Feb 11, 1986
INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
K854987 · HWE
Richard Wolf Medical Instruments Corp.
Orthopedic · 61d
Cleared Feb 11, 1986
EMDS GLUCOSE TEST PACK ITEM 67656/95
K855080 · LFR
Em Diagnostic Systems, Inc.
Chemistry · 54d
Cleared Feb 11, 1986
KMW HIP PROSTHESIS POROUS COATED
K855123
Kirkschner Medical Corp.
Orthopedic · 50d
Cleared Feb 11, 1986
COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER
K855149 · JJQ
Hyperion, Inc.
Chemistry · 47d
Cleared Feb 11, 1986
GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD
K855203 · FMK
Miles Laboratories, Inc.
General & Plastic Surgery · 47d
Cleared Feb 11, 1986
FEMORAL HEMI-HIP PROSTHESES
K855228 · KWL
Orthopaedic Device Corp.
Orthopedic · 43d
Cleared Feb 11, 1986
DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM
K860021 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 39d
Cleared Feb 11, 1986
CALCIUM (CPC) REAGENT SET
K860044 · CIC
Sterling Diagnostics, Inc.
Chemistry · 36d
Cleared Feb 11, 1986
SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS
K860074
Warsaw Orthopedic, Inc.
Orthopedic · 35d
Cleared Feb 11, 1986
CPK REAGENT SET (COLORIMETRIC)
K860096 · CGS
Sterling Diagnostics, Inc.
Chemistry · 32d
Cleared Feb 11, 1986
THERAPEUTIC DRUG (TDM) CALIBRATOR
K860097 · DIF
Instrumentation Laboratory CO
Toxicology · 32d
Cleared Feb 11, 1986
GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET
K860110 · CKA
Technostics Intl.
Chemistry · 29d