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
94729–94752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1997
SYMPACATH HYDROGEL COATED FOLEY
K964575 · EZL
Rusch Intl.
Gastroenterology & Urology · 82d
Cleared Feb 04, 1997
MRT-35A V9.0
K964608 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Feb 04, 1997
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
K964670 · LFW
Roche Diagnostic Systems, Inc.
Toxicology · 75d
Cleared Feb 04, 1997
TCB TEMPORARY CROWN AND BRIDGE MATERIAL
K964691 · EBG
Scican
Dental · 74d
Cleared Feb 04, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH...
K964720 · CGJ
Johnson & Johnson Clinical...
Chemistry · 71d
Cleared Feb 04, 1997
DE-TOX CONTROL 1 AND DE-TOX CONTROL 19
K964771 · DIF
Dyna-Tek Industries
Toxicology · 69d
Cleared Feb 04, 1997
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
K964864 · LLH
Alexon Biomedical, Inc.
Microbiology · 62d
Cleared Feb 04, 1997
FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
K964892 · FJL
Gynecare Innovation Center
Gastroenterology & Urology · 60d
Cleared Feb 04, 1997
ALKALINE PHOSPHATASE
K964914 · CJE
Derma Media Lab., Inc.
Chemistry · 57d
Cleared Feb 04, 1997
MINK LUNG CELL CULTURE
K965047 · KIR
Neogenex
Microbiology · 48d
Cleared Feb 04, 1997
CETIBUTEN, 30MCG, SENSI-DISC
K965159 · JTN
Becton Dickinson Microbiology Systems
Immunology · 43d
Cleared Feb 04, 1997
STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
K965166 · JJT
Specialized Assays, Inc.
Chemistry · 42d
Cleared Feb 04, 1997
STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)
K965168 · JJT
Specialized Assays, Inc.
Chemistry · 42d
Cleared Feb 04, 1997
PERFECTA PREGNANCY TEST
K965184 · LCX
Wyntek Diagnostics, Inc.
Chemistry · 42d
Cleared Feb 04, 1997
OSOM CLASSIC HCG-URINE TEST (115)
K965227 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 36d
Cleared Feb 03, 1997
HEDROCEL ACETABULAR RESTRICTOR
K962468 · JDI
Implex Corp.
Orthopedic · 223d
Cleared Feb 03, 1997
TOTALCARE
K962942 · FNL
Hill-Rom, Inc.
General Hospital · 189d
Cleared Feb 03, 1997
FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
K963248 · DYG
J-Lloyd Medical, Inc.
Cardiovascular · 168d
Cleared Feb 03, 1997
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
K963671 · JDI
Osteonics Corp.
Orthopedic · 143d
Cleared Feb 03, 1997
SYS STIM 226
K964028 · IPF
Mettler Electronics Corp.
Physical Medicine · 119d
Cleared Feb 03, 1997
RTA RETINAL THICKNESS ANALYZER
K964137 · HLI
Talia Technology , Ltd.
Ophthalmic · 111d
Cleared Feb 03, 1997
SMARTOAE
K964426 · EWO
Intelligent Hearing Systems
Ear, Nose, Throat · 90d
Cleared Feb 03, 1997
IAMIN WET DRESSING (COPPER-SALINE)
K964468 · MGQ
Procyte Corp.
General & Plastic Surgery · 89d
Cleared Feb 03, 1997
RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
K964472 · KYI
Biologically Oriented Prostheses
Orthopedic · 88d