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
76153–76176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN...
K020182 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 06, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN...
K020185 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN...
K020209 · LON
Dade Behring, Inc.
Microbiology · 15d
Cleared Feb 06, 2002
R & D BODY FLUID CONTROL
K020229 · JPK
R&D Systems, Inc.
Hematology · 14d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25,...
K020246 · LON
Dade Behring, Inc.
Microbiology · 13d
Cleared Feb 06, 2002
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
K020249 · LON
Dade Behring, Inc.
Microbiology · 13d
Cleared Feb 06, 2002
LOGIQ 3
K020263 · IYN
General Electric Co.
Radiology · 12d
Cleared Feb 05, 2002
CENTRIFUGAL PUMP
K011838 · DWA
Stockert Instrumente GmbH
Cardiovascular · 238d
Cleared Feb 05, 2002
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
K012274 · LDD
Medtronic Physio-Control Corp.
Cardiovascular · 201d
Cleared Feb 05, 2002
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE...
K012463 · GXY
Everyway Medical Instruments Co.,Ltd
Neurology · 188d
Cleared Feb 05, 2002
VASCUPUNCTURE ACCESS WIRE
K012861 · DQX
Neometrics, Inc.
Cardiovascular · 165d
Cleared Feb 05, 2002
TRAPSYSTEM SET
K013692 · KNW
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 90d
Cleared Feb 05, 2002
ORTHOSIS HELMET MOLDING
K013700 · MVA
Precision Prosthetics & Orthotics, Inc.
Neurology · 89d
Cleared Feb 05, 2002
BECKER BAND CRANIAL REMOLDING ORTHOSIS
K013719 · MVA
Becker Orthopedic Appliance Co.
Neurology · 89d
Cleared Feb 05, 2002
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
K013891 · DZE
Institut Straumann AG
Dental · 74d
Cleared Feb 05, 2002
CANVAS N-VAS-D 2.0
K014011 · LNH
Vassol, Inc.
Radiology · 62d
Cleared Feb 05, 2002
CTL BODY / SPINE ARRAY COIL
K014086 · MOS
Usa Instruments, Inc.
Radiology · 56d
Cleared Feb 05, 2002
ERECAID CLASSIC SYSTEM
K020082 · LKY
Endocare, Inc.
Gastroenterology & Urology · 26d
Cleared Feb 05, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K020141 · KTT
Ebi, L.P.
Orthopedic · 20d
Cleared Feb 05, 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155 · KWP
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Feb 04, 2002
MEDIGROUP CATHETER EXTENDER/REPAIR KIT
K012502 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 185d
Cleared Feb 04, 2002
ADVANCED AIR PURIFICATION SYSTEM
K012549 · FRF
Healthway Products, Inc.
General Hospital · 181d
Cleared Feb 04, 2002
REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
K012676 · HWE
Adven Medical
Orthopedic · 174d
Cleared Feb 04, 2002
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
K012694 · HWE
Adven Medical
Orthopedic · 174d