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
90289–90312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 13, 1998
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS...
K974318 · JOW
Healthcare Service and Supply
Cardiovascular · 88d
Cleared Feb 13, 1998
EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
K974335 · DXE
J-Lloyd Medical, Inc.
Cardiovascular · 87d
Cleared Feb 13, 1998
CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
K974336 · GCJ
J-Lloyd Medical, Inc.
General & Plastic Surgery · 87d
Cleared Feb 13, 1998
MITEK KNOTLESS ANCHOR
K974345 · MBI
Mitek Products
Orthopedic · 86d
Cleared Feb 13, 1998
ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING
K974348 · FRO
Laboratoires Urgo S.A.
General & Plastic Surgery · 86d
Cleared Feb 13, 1998
ADVANTX LCN, ADVANTX LCLP
K974367 · IZI
GE Medical Systems
Radiology · 85d
Cleared Feb 13, 1998
EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE
K974437 · KGI
Lunar Corp.
Radiology · 81d
Cleared Feb 13, 1998
NUMASTATION
K974444 · KPS
Numa, Inc.
Radiology · 80d
Cleared Feb 13, 1998
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
K974779 · JJE
Abbott Laboratories
Chemistry · 53d