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
87817–87840 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1998
CELL ROBOTICS' LASETTE
K981746 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 203d
Cleared Dec 07, 1998
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K981917 · LYY
Oon Corp. Resources
General Hospital · 189d
Cleared Dec 07, 1998
GREEN-OR DENTIN DESENSITIZER
K981972 · LBH
Centrix, Inc.
Dental · 186d
Cleared Dec 07, 1998
REAADS IGG ANTI-B2GPI TEST KIT
K982391 · MSV
Corgenix, Inc.
Immunology · 151d
Cleared Dec 07, 1998
REAADS IGM ANTI-B2GP1 TEST KIT
K982433 · MSV
Corgenix, Inc.
Immunology · 146d
Cleared Dec 07, 1998
NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C
K982728 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 124d
Cleared Dec 07, 1998
KSEA C-MOUNT ARTHROSCOPES
K983142 · HRX
Karl Storz Endoscopy
Orthopedic · 90d
Cleared Dec 07, 1998
ARSOFT
K983146 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 90d
Cleared Dec 07, 1998
NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900
K983219 · CBK
Drager, Inc.
Anesthesiology · 84d
Cleared Dec 07, 1998
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
K983263 · LOJ
Diagnostic Products Corp.
Immunology · 81d
Cleared Dec 07, 1998
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
K983345 · JJE
Bayer Corp.
Chemistry · 75d
Cleared Dec 07, 1998
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508 · HWC
Osteonics Corp.
Orthopedic · 61d
Cleared Dec 07, 1998
ANTI-TG IGG ELISA TEST SYSTEM
K983553 · JZO
Columbia Bioscience, Inc.
Immunology · 59d
Cleared Dec 07, 1998
POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE
K983721 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 46d
Cleared Dec 07, 1998
CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K983723 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 46d
Cleared Dec 07, 1998
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE
K983725 · LZA
Omnigrace , Ltd.
General Hospital · 46d
Cleared Dec 07, 1998
ABBOTT ARCHITECT FERRITIN
K983759 · DBF
Abbott Laboratories
Immunology · 42d
Cleared Dec 07, 1998
IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
K983972 · MMI
Diagnostic Products Corp.
Chemistry · 28d
Cleared Dec 07, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS
K984011 · JJX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Dec 04, 1998
ELECTROSURGICAL UNIT
K981781 · GEI
Hill-Med, Inc.
General & Plastic Surgery · 198d
Cleared Dec 04, 1998
CUE AMBULATORY VOLUMETRIC INFUSION PUMP
K981816 · FRN
Becton Dickinson Curlin, LLC
General Hospital · 196d
Cleared Dec 04, 1998
HUMAN IGA SUBCLASS BNII COMBI KIT
K981912 · CFN
The Binding Site, Ltd.
Immunology · 186d
Cleared Dec 04, 1998
ULNAR HEAD IMPLANT
K982268 · KXE
Avanta Orthopaedics, Inc.
Orthopedic · 158d
Cleared Dec 04, 1998
RAPPORT V.T.D.
K982275 · LKY
Owen Mumford USA, Inc.
Gastroenterology & Urology · 158d