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
79153–79176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2001
PNS MAGNETIC STIMULATOR SYSTEM
K002889 · KOI
Neotonus, Inc.
Anesthesiology · 203d
Cleared Apr 06, 2001
LPC-PLUS ACETABULAR CUP
K003274 · LZO
Plus Orthopedics
Orthopedic · 170d
Cleared Apr 06, 2001
PREAMP CABLE, MODEL B400-1011PA
K003542 · DQA
Beta Biomed Services, Inc.
Anesthesiology · 140d
Cleared Apr 06, 2001
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K010100 · KRR
Howmedica Osteonics Corp.
Orthopedic · 85d
Cleared Apr 06, 2001
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
K010124 · KWS
Arthrex, Inc.
Orthopedic · 80d
Cleared Apr 06, 2001
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
K010171 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 78d
Cleared Apr 06, 2001
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES...
K010776 · MNH
Corin USA
Orthopedic · 23d
Cleared Apr 06, 2001
T2 FEMORAL NAIL
K010801 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Apr 06, 2001
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
K010883 · ITX
Teratech Corp.
Radiology · 14d
Cleared Apr 06, 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · FRN
Abbott Laboratories
General Hospital · 10d
Cleared Apr 05, 2001
PERIFORM PERINEOMETRIC PROBE, MODEL 8300
K002617 · HIR
Neen Design , Ltd.
Gastroenterology & Urology · 225d
Cleared Apr 05, 2001
FRSENIUS PD IQCARD CYCLER
K002892 · FKX
Fresenius Medical Care North America
Gastroenterology & Urology · 202d
Cleared Apr 05, 2001
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE...
K003350 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 161d
Cleared Apr 05, 2001
SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)
K003701 · JOW
Sentech Medical Systems, Inc.
Cardiovascular · 125d
Cleared Apr 05, 2001
NUVOLASE 532 MEDICAL LASER SYSTEM
K010046 · GEX
American Laser Corp.
General & Plastic Surgery · 90d
Cleared Apr 05, 2001
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
K010129 · LNI
Toshiba America Medical Systems, In.C
Radiology · 79d
Cleared Apr 05, 2001
VERSALUX
K010133 · EBZ
Centrix, Inc.
Dental · 78d
Cleared Apr 05, 2001
TOTAL CURE
K010196 · EBF
Bisco, Inc.
Dental · 73d
Cleared Apr 05, 2001
PJUR EROS WATER FORMULATION
K010199 · NUC
L.C.C. Pjur Group Germany
Obstetrics & Gynecology · 73d
Cleared Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236 · DCK
Beckman Coulter, Inc.
Immunology · 70d
Cleared Apr 05, 2001
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
K010377 · KZH
Minimed, Inc.
General Hospital · 56d
Cleared Apr 05, 2001
VERDICT -II BAR/BZO
K010561 · DIS
Medtox Diagnostics, Inc.
Toxicology · 38d
Cleared Apr 05, 2001
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO
K010564 · DKZ
Medtox Diagnostics, Inc.
Toxicology · 38d
Cleared Apr 05, 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · JHI
Sa Scientific, Inc.
Chemistry · 36d