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
70177–70200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2003
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO...
K032772 · HGM
Hill-Rom Manufacturing, Inc.
Obstetrics & Gynecology · 30d
Cleared Oct 08, 2003
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
K032795 · LNH
Ge Medical Systems, LLC
Radiology · 30d
Cleared Oct 08, 2003
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
K032960 · LLZ
Wide Corporation
Radiology · 15d
Cleared Oct 07, 2003
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
K023366 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 364d
Cleared Oct 07, 2003
NICO WITH MARS, MODEL 7300
K030886 · CCK
Respironics Novametrix, Inc.
Anesthesiology · 200d
Cleared Oct 07, 2003
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · KMF
3M Company
General & Plastic Surgery · 169d
Cleared Oct 07, 2003
VIGORMIST COMPRESSOR NEBULIZER
K031413 · BTI
Vega Technologies, Inc.
Anesthesiology · 155d
Cleared Oct 07, 2003
CSS
K031564 · GEI
Medical Scientific, Inc.
General & Plastic Surgery · 141d
Cleared Oct 07, 2003
I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3
K031873 · JJX
I-Stat Corporation
Chemistry · 112d
Cleared Oct 07, 2003
BETEC RETRACTABLE SAFETY SYRINGE (5ML)
K031909 · MEG
Betec Medical Science Co., Ltd.
General Hospital · 109d
Cleared Oct 07, 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE,...
K032098 · HWC
Arthrex, Inc.
Orthopedic · 91d
Cleared Oct 07, 2003
NUVASIVE CEMENT RESTRICTOR
K032180 · JDK
Nuvasive, Inc.
Orthopedic · 82d
Cleared Oct 07, 2003
DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT
K032195 · DYH
Dentaurum
Dental · 81d
Cleared Oct 07, 2003
BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
K032323 · LYZ
Long First (Xiamen) Plastics Co., Ltd.
General Hospital · 71d
Cleared Oct 07, 2003
JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE
K032411 · DQX
Js Vascular, Inc.
Cardiovascular · 63d
Cleared Oct 07, 2003
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
K032603 · KIF
Meta Biomed Co., Ltd.
Dental · 43d
Cleared Oct 07, 2003
MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS
K033039 · MEB
Mckinley, Inc.
General Hospital · 8d
Cleared Oct 06, 2003
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
K024072 · MSS
Duckworth & Kent, Ltd.
Ophthalmic · 300d
Cleared Oct 06, 2003
CSF400 AND CSF600
K030081 · JXG
Inmed Ltda.
Neurology · 270d
Cleared Oct 06, 2003
COACH 777-3
K030756 · INI
Wheelchair & Scooter Express
Physical Medicine · 209d
Cleared Oct 06, 2003
COACH 777-4
K030757 · INI
Wheelchair & Scooter Express
Physical Medicine · 209d
Cleared Oct 06, 2003
LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX
K031386 · LYY
Lalan Gloves (Pvt) , Ltd.
General Hospital · 158d
Cleared Oct 06, 2003
OPTIBAND LC
K032407 · DYH
Sybron Dental Specialties, Inc.
Dental · 63d
Cleared Oct 06, 2003
F-10 FOLDING POWER CHAIR
K032441 · ITI
Wheelchair & Scooter Express
Physical Medicine · 60d