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
106609–106632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1994
CUTANEOUS ELECTRODE
K933802 · GXY
Cadwell Laboratories, Inc.
Neurology · 399d
Cleared Sep 07, 1994
NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION
K934166 · JWH
Corin Orthopedic Products
Orthopedic · 376d
Cleared Sep 07, 1994
SIEMENS MODEL 584 P-2
K934752 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 338d
Cleared Sep 07, 1994
INFINITY 252
K935019 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 322d
Cleared Sep 07, 1994
CONTINUOUS IRRIGATION CYSTOURETHROSCOPE
K935163 · FBO
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 313d
Cleared Sep 07, 1994
STONE EXTRACTOR, GRASPING FORCEPS
K935737 · FFL
Boston Scientific Corp
Gastroenterology & Urology · 280d
Cleared Sep 07, 1994
ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT
K936079 · JWH
Exactech, Inc.
Orthopedic · 259d
Cleared Sep 07, 1994
VENTANA EMA PRIMARY ANDIBODY
K940243 · DHF
Ventana Medical Systems, Inc.
Immunology · 231d
Cleared Sep 07, 1994
KARL STORZ THORACIC SURGERY INSTRUMENTS
K940427 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 219d
Cleared Sep 07, 1994
ACCESS(R) TOTAL T3
K940833 · CDP
Bio-Rad Laboratories, Inc.
Chemistry · 196d
Cleared Sep 07, 1994
UNIPOWER RECHARGEABLE BATTERY PACK
K940842 · LDD
Unipower Corp.
Cardiovascular · 196d
Cleared Sep 07, 1994
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT
K941168 · CHP
Incstar Corp.
Chemistry · 177d
Cleared Sep 07, 1994
CEDIA DAU OPIATE ASSAY
K941195 · DJG
Microgenics Corp.
Toxicology · 177d
Cleared Sep 07, 1994
OCTEIA INTACT PTH
K941878 · CEW
I.D.S.
Chemistry · 142d
Cleared Sep 07, 1994
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · CEP
Bd Becton Dickinson Vacutainer...
Chemistry · 96d
Cleared Sep 07, 1994
HALL MICROCHOICE ELECTRIC POWERED SYSTEM
K942660 · HWE
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 93d
Cleared Sep 07, 1994
HUMAN IGG SUBCLASSES ELISA COMBI KIT
K943098 · DAS
Research Diagnostics, Inc.
Immunology · 71d
Cleared Sep 07, 1994
SURGICAL DRAPES
K943122 · KKX
Mallinckrodt Group, Inc.
General Hospital · 70d
Cleared Sep 07, 1994
HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)
K943205 · DAS
Research Diagnostics, Inc.
Immunology · 64d
Cleared Sep 07, 1994
MAX FRAME DESIGN
K943913 · HQZ
Noble Optic
Ophthalmic · 27d
Cleared Sep 07, 1994
MONOPOLAR ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS
K943958 · GCJ
Tnco, Inc.
General & Plastic Surgery · 23d
Cleared Sep 07, 1994
SABRE ULTIMATE SHIELDED TROCAR
K943976 · GCJ
Endoscopic Concepts, Inc.
General & Plastic Surgery · 23d
Cleared Sep 07, 1994
FREEDOM ASPIRATOR, MODEL 6000
K944116 · BTA
Stackhouse, Inc.
General & Plastic Surgery · 15d
Cleared Sep 06, 1994
FULL SPECTRUM ULE FIBER, MODEL FF101
K920596 · GEX
Gerald J. Shirk, M.D.
General & Plastic Surgery · 938d