FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127657–127680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1990
SIEMENS ENDO-P-PROBE
K897098 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 64d
Cleared Feb 23, 1990
COULTER AST (GOT) REAGENT
K897165 · CIT
Coulter Electronics, Inc.
Chemistry · 57d
Cleared Feb 23, 1990
COULTER TOTAL PROTEIN REAGENT
K897166 · CEK
Coulter Electronics, Inc.
Chemistry · 57d
Cleared Feb 23, 1990
QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
K897169 · CDT
Photec Diagnostics, Inc.
Chemistry · 57d
Cleared Feb 23, 1990
BIOTRACK IMMUNOCHEMISTRY MONITOR
K900372 · JJQ
Biotrack, Inc.
Toxicology · 28d
Cleared Feb 23, 1990
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
K900498 · LZG
Cardiac Pacemakers, Inc.
General Hospital · 36d
Cleared Feb 23, 1990
MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE
K900586 · LLZ
Medrad, Inc.
Radiology · 16d
Cleared Feb 23, 1990
SERATEST ENA [SSA] KIT
K900617 · LLL
Hemagen Diagnostics, Inc.
Immunology · 15d
Cleared Feb 22, 1990
SPATULA FOR PAP SMEAR COLLECTION
K893229 · HHT
Medical Device Inspection Co., Inc.
Obstetrics & Gynecology · 300d
Cleared Feb 22, 1990
TYPE EXPIRED CO2 9270, CAPNOGRAPH
K895001 · CCK
S & W Medico Teknik
Anesthesiology · 203d
Cleared Feb 22, 1990
STERILE SURGEON'S GLOVES (C T R GLOVES)
K895230 · KGO
Tan D. W. Trading Co., Inc.
General Hospital · 191d
Cleared Feb 22, 1990
DEN-MAT LAMI-QUICK
K895269 · ELL
Den-Mat Corp.
Dental · 183d
Cleared Feb 22, 1990
STEAM STERILIZER (AUTOCLAVE), DENTAL
K895638 · FLE
Porter Instrument Co., Inc.
General Hospital · 156d
Cleared Feb 22, 1990
ACCU-BEAM WAVEGUIDE
K895656 · GEX
Tti Medical
General & Plastic Surgery · 156d
Cleared Feb 22, 1990
SHOWER CHAIRS
K895740 · FPO
Lumex, Inc.
General Hospital · 149d
Cleared Feb 22, 1990
MODEL 219 TELEMETRY SYSTEM
K895895 · GYE
Mennen Medical, Inc.
Neurology · 139d
Cleared Feb 22, 1990
LOPER CELIAC PLEXUS BLOCK CATHETER KIT
K895955 · CAZ
Opticon Medical, Inc.
Anesthesiology · 134d
Cleared Feb 22, 1990
TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING
K895971 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 132d
Cleared Feb 22, 1990
KELLER PULSE OXIMETER - KMS 850
K895987 · DQA
Keller Medical Specialties Products,...
Anesthesiology · 133d
Cleared Feb 22, 1990
S-ROM(TM)/NOILES(TM) MARK 5 KNEE
K896397 · JWH
Joint Medical Products Corp.
Orthopedic · 107d
Cleared Feb 22, 1990
GRANITEC Z2, ZINC PHOSPHATE CEMENT
K896649 · EMA
Confi-Dental Products Co.
Dental · 90d
Cleared Feb 22, 1990
LORENZ STENT
K896667 · FWN
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 87d
Cleared Feb 22, 1990
BICORE VARIFLEX(R) FLOW TRANSDUCER
K896718 · BYR
Bicore Monitoring Systems
Anesthesiology · 85d
Cleared Feb 22, 1990
PRIMER-P ADHESIVE AGENT
K896719 · EBI
Parkell
Dental · 85d