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
73009–73032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2002
AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114...
K023212 · GXY
Ag Garments
Neurology · 78d
Cleared Dec 13, 2002
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
K023229 · IZH
American Mammographics, Inc.
Radiology · 77d
Cleared Dec 13, 2002
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K023233 · BSO
Ebi, L.P.
Anesthesiology · 77d
Cleared Dec 13, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K023243 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 74d
Cleared Dec 13, 2002
ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
K023261 · GCJ
Taut, Inc.
General & Plastic Surgery · 74d
Cleared Dec 13, 2002
APEX HRI DIGITAL RADIOGRAPHY SYSTEM
K023292 · MUH
Krugman Technologies, Inc.
Radiology · 72d
Cleared Dec 13, 2002
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
K023383 · MQF
Cooper Surgical
Obstetrics & Gynecology · 66d
Cleared Dec 13, 2002
COOPERSURGICAL TRIAL TRANSFER CATHETER
K023384 · MQF
Cooper Surgical
Obstetrics & Gynecology · 66d
Cleared Dec 13, 2002
SPERMGRAD, MODELS 10022/10063
K023403 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 64d
Cleared Dec 13, 2002
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
K023415 · KWP
Medtronic Sofamor Danek
Orthopedic · 63d
Cleared Dec 13, 2002
TULIP ALGINATE IMPRESSION MATERIAL
K023466 · ELW
Cavex Holland BV
Dental · 58d
Cleared Dec 13, 2002
BIOLOY
K023477 · EJH
Neirynck & Vogt NV
Dental · 58d
Cleared Dec 13, 2002
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
K023491 · FRN
Help Technologies
General Hospital · 57d
Cleared Dec 13, 2002
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
K023500 · FLL
Innovatech, Inc.
General Hospital · 56d
Cleared Dec 13, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN...
K023541 · LON
Dade Behring, Inc.
Microbiology · 52d
Cleared Dec 13, 2002
ENHANCE HTF MEDIUM WITH HEPES
K023655 · MQL
Conception Technologies
Obstetrics & Gynecology · 44d
Cleared Dec 13, 2002
SPERM WASH MEDIUM WITH GENTAMICIN
K023717 · MQL
Conception Technologies
Obstetrics & Gynecology · 38d
Cleared Dec 13, 2002
COLUMBUS (CR) TOTAL KNEE SYSTEM
K023788 · JWH
Aesculap, Inc.
Orthopedic · 30d
Cleared Dec 13, 2002
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797 · KWP
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Dec 13, 2002
PARAGON INFUSION SYSTEM WITH BOLUS
K023827 · FRN
I-Flow Corp.
General Hospital · 25d
Cleared Dec 13, 2002
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K023832 · NBW
Lifescan, Inc.
Chemistry · 25d
Cleared Dec 13, 2002
K-ASSAY LP(A) CONTROLS
K023853 · DFC
Kamiya Biomedical Co.
Immunology · 24d
Cleared Dec 13, 2002
MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
K023938 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 17d
Cleared Dec 12, 2002
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM
K013562 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 412d