FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95233–95256 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1997
BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
K961968 · LQL
Bd Becton Dickinson Vacutainer...
Microbiology · 260d
Cleared Feb 04, 1997
MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP...
K962653 · FAS
Microgyn Corp.
Gastroenterology & Urology · 211d
Cleared Feb 04, 1997
9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
K963104 · DSP
Arrow Intl., Inc.
Cardiovascular · 179d
Cleared Feb 04, 1997
HERPES GROUP IGG ELISA TEST SYSTEM
K963645 · LGC
Armkel, LLC
Microbiology · 145d
Cleared Feb 04, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
K963673 · KLT
Beckman Instruments, Inc.
Chemistry · 144d
Cleared Feb 04, 1997
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
K964245 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 103d
Cleared Feb 04, 1997
MIRACLE - EAR (ITE/ITC/CIC)
K964419 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 126d
Cleared Feb 04, 1997
PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM
K964485 · IYE
Eliav , Ltd.
Radiology · 88d
Cleared Feb 04, 1997
SLEEPWIZARD
K964494 · MNR
Nellcor Puritan Bennett, Inc.
Anesthesiology · 88d
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