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
102577–102600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1995
S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS
K951084 · JDI
Joint Medical Products Corp.
Orthopedic · 83d
Cleared May 31, 1995
SCIMED GATEWAY PLUS
K951089 · DTL
Scimed Life Systems, Inc.
Cardiovascular · 83d
Cleared May 31, 1995
PULPDENT GLASS IONOMER CEMENTS
K951270 · EMA
Pulpdent Corp.
Dental · 71d
Cleared May 31, 1995
SUNLITE 1275
K951465 · EBZ
Fen Dental Mfg., Inc.
Dental · 62d
Cleared May 31, 1995
NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND...
K951733 · GCJ
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 47d
Cleared May 31, 1995
DEGUSTAR GA-2
K951777 · EJT
Degussa Corp.
Dental · 44d
Cleared May 31, 1995
DEGUDENT U
K951778 · EJT
Degussa Corp.
Dental · 47d
Cleared May 31, 1995
OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK
K951811 · LRP
Osteotech, Inc.
General & Plastic Surgery · 42d
Cleared May 31, 1995
CARDON PHYSICAL THERAPY TABLE MODEL R27112
K951952 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 35d
Cleared May 31, 1995
CARDON PHSICAL THERAPY TABLE MODEL R27630
K951953 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 35d
Cleared May 31, 1995
CARDON PHYSICAL THERAPY TABLE MODEL R27108
K951954 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 35d
Cleared May 31, 1995
ACCU-BEAM FIBER OPTIC HANDPIECE
K952006 · GEX
Tti Medical
General & Plastic Surgery · 33d
Cleared May 31, 1995
E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS
K952053 · FPA
Becton Dickinson Vascular Access, Inc.
General Hospital · 30d
Cleared May 30, 1995
EPI-SPINAL ANESTHESIA TRAY
K941153 · CAZ
Preferred Medical Products
Anesthesiology · 445d
Cleared May 30, 1995
INSTACINE
K942558 · LMB
Fidelity Medical, Inc.
Radiology · 364d
Cleared May 30, 1995
CONTINUOUS FLOW BIOPSY PROBE
K942626 · FDC
Gm Engineering, Inc.
Gastroenterology & Urology · 362d
Cleared May 30, 1995
INFINITY SHOULDER SYSTEM
K943908 · HSD
Wrightmedicaltechnologyinc
Orthopedic · 292d
Cleared May 30, 1995
ETHICON NONABSORBABLE SUTURE ANCHOR
K943950 · JDR
Ethicon, Inc.
Orthopedic · 288d
Cleared May 30, 1995
ISOLA OPEN AND CLOSED SCREWS
K944756 · MNH
Acromed Corp.
Orthopedic · 246d
Cleared May 30, 1995
CUSTOM ARTIFICIAL HUMAN EYES
K945270 · HQH
Daniel T Acosta
Ophthalmic · 214d
Cleared May 30, 1995
OSTEONICS(R) CCR HIP STEM SERIES
K945574 · JDI
Osteonics Corp.
Orthopedic · 197d
Cleared May 30, 1995
ALTRA NOVA(TM) 170 HEMODIALYZER
K945621 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 196d
Cleared May 30, 1995
ALTRA NOVA(TM) 140 HEMODIALYZER
K945625 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 196d
Cleared May 30, 1995
ORTHOMET TITANIUM HYBRID FEMORAL STEM
K945783 · JDG
Orthomet, Inc.
Orthopedic · 186d