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
90793–90816 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1998
FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
K973483 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 155d
Cleared Feb 17, 1998
INFUSION DYNAMICS POWER INFUSER
K974074 · KZD
Infusion Dynamics, Inc.
General Hospital · 111d
Cleared Feb 17, 1998
WIELISA MPO ANCA TEST SYSTEM
K974166 · MOB
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA PR-3 ANCA TEST SYSTEM
K974167 · MOB
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA ANTI-GBM TEST SYSTEM
K974169 · DBL
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
K974355 · OWB
Ge Dec Medical Systems
Radiology · 90d
Cleared Feb 17, 1998
RAPET RF
K974370 · DHR
Stanbio Laboratory
Immunology · 89d
Cleared Feb 17, 1998
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
K974505 · DBF
Alfa Biotech (Uk) , Ltd.
Immunology · 78d
Cleared Feb 17, 1998
TRUE VISION, TRUE VISION II
K974542 · EIA
Medical Dynamics, Inc.
Dental · 76d
Cleared Feb 17, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
K974564 · DEB
Beckman Instruments, Inc.
Immunology · 74d
Cleared Feb 17, 1998
ORGENTEC ANTI-MPO (P-ANCA) ELISA
K974701 · MOB
American Laboratory Products Co., Ltd.
Immunology · 71d
Cleared Feb 17, 1998
ORGENTEC ANTI-PR3 (C-ANCA) ELISA
K974702 · MOB
American Laboratory Products Co., Ltd.
Immunology · 71d
Cleared Feb 17, 1998
ALEX TA2 ERASER
K980131 · GEX
Light Age, Inc.
General & Plastic Surgery · 33d
Cleared Feb 17, 1998
T.B.Q. RTU
K980369 · LRJ
STERIS Corporation
General Hospital · 18d
Cleared Feb 13, 1998
ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET
K970229 · DYB
Arrow Intl., Inc.
Cardiovascular · 388d
Cleared Feb 13, 1998
RUSCH TRACHEOFIX-SET
K972423 · JOH
Rusch Intl.
Anesthesiology · 231d
Cleared Feb 13, 1998
THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM
K973191 · BTR
Pulmonx
Anesthesiology · 172d
Cleared Feb 13, 1998
EPISCREEN ORAL SPECIMEN COLLECTION DEVICE
K973395 · PJD
Epitope, Inc.
Chemistry · 176d
Cleared Feb 13, 1998
NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
K973459 · KGI
Norland Corp.
Radiology · 154d
Cleared Feb 13, 1998
STC CANNABINOIDS MICRO-PLATE EIA
K973750 · LDJ
OraSure Technologies, Inc.
Toxicology · 135d
Cleared Feb 13, 1998
GALILEO DISPOSABLE HYSTEROSCOPES
K974297 · HIH
Netoptix Corp.
Obstetrics & Gynecology · 88d
Cleared Feb 13, 1998
PANACRYL
K974299 · GAM
Ethicon, Inc.
General & Plastic Surgery · 88d
Cleared Feb 13, 1998
RTR-2000/RTR-4000
K974307 · JAK
Terarecon,Inc.
Radiology · 88d
Cleared Feb 13, 1998
HYDROFERA FEMORAL WICK
K974316 · EFQ
Hydrofera, LLC
General & Plastic Surgery · 88d