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
72313–72336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2003
VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072
K030246 · FPA
Victus, Inc.
General Hospital · 33d
Cleared Feb 26, 2003
INTERFERENTIAL STIMULATOR, MODEL RTM1000
K030254 · IPF
Ryan Telemedicine
Physical Medicine · 33d
Cleared Feb 26, 2003
QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030
K030264 · DTZ
Jostra AG
Cardiovascular · 30d
Cleared Feb 26, 2003
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700,...
K030289 · JXG
Integra Lifesciences Corp.
Neurology · 29d
Cleared Feb 26, 2003
HEM-O-LOK XL CLIP
K030311 · FZP
Weck
General & Plastic Surgery · 27d
Cleared Feb 26, 2003
ZEPHIR ANTERIOR CERVICAL SYSTEM
K030327 · KWQ
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Feb 26, 2003
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383 · MNH
Depuyacromed
Orthopedic · 21d
Cleared Feb 26, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K030431 · MHX
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Feb 26, 2003
MODIFICATION TO THE MAESTRO SYSTEM
K030463 · DZE
BioHorizons Implant Systems, Inc.
Dental · 14d
Cleared Feb 26, 2003
SENORX ES-300
K030473 · GEI
Senorx, Inc.
General & Plastic Surgery · 14d
Cleared Feb 25, 2003
JAX
K010555 · MQV
Smith & Nephew, Inc.
Orthopedic · 729d
Cleared Feb 25, 2003
U2 ACETABULAR CUP
K022520 · LPH
United Orthopedic Corp.
Orthopedic · 210d
Cleared Feb 25, 2003
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
K023949 · HAW
Image-Guided Neurologics, Inc.
Neurology · 90d
Cleared Feb 25, 2003
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE...
K024100 · LIH
Theratech, Inc.
Neurology · 75d
Cleared Feb 25, 2003
MICROSURGICAL BIPOLAR HANDPIECE
K024304 · GEI
Neomedix Corp.
General & Plastic Surgery · 63d
Cleared Feb 25, 2003
FIRST RESPONSE PREGNANCY TEST
K030258 · LCX
Armkel, LLC
Chemistry · 32d
Cleared Feb 25, 2003
MODIFICATION TO TSRH SPINAL SYSTEM
K030285 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Feb 25, 2003
TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX
K030299 · FLL
Oriental System Technology, Inc.
General Hospital · 27d
Cleared Feb 25, 2003
UNICONDYLAR FEMORAL COMPONENT
K030301 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Feb 24, 2003
MEDCOMP SC4
K022678 · MSD
Medcomp
Gastroenterology & Urology · 196d
Cleared Feb 24, 2003
OXYBOX SYSTEM
K023456 · KPJ
Oxyfast Corporation
General & Plastic Surgery · 132d
Cleared Feb 24, 2003
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A,...
K023931 · HGM
Philips Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 24, 2003
CLOCKMINI, MODEL DF301
K023942 · MNW
Yamato Corp.
Gastroenterology & Urology · 90d
Cleared Feb 24, 2003
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
K024210 · DGC
Beckman Coulter, Inc.
Immunology · 66d