FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
124177–124200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1990
XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
K901514 · DSK
Ppg Industries, Inc.
Cardiovascular · 231d
Cleared Nov 16, 1990
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
K902722 · HET
Davol, Inc.
Obstetrics & Gynecology · 149d
Cleared Nov 16, 1990
1.9 FRENCH LITHOTRIPTER ELECTRODE
K903337 · FFK
Northgate Research, Inc.
Gastroenterology & Urology · 114d
Cleared Nov 16, 1990
DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER
K903437 · DRO
Keller Medical Specialties Products,...
Cardiovascular · 108d
Cleared Nov 16, 1990
INTERSPEC APOGEE
K903839 · DXK
Interspec, Inc.
Cardiovascular · 87d
Cleared Nov 16, 1990
DATASCOPE PERCOR STAT DL 10.5 FR 50CC
K903930 · DSP
Datascope Corp.
Cardiovascular · 84d
Cleared Nov 16, 1990
STERILE WATER SOLUTION CATALOG # 10000
K904216 · JOL
Superior Healthcare Group, Inc.
General Hospital · 65d
Cleared Nov 15, 1990
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
K903004 · GWQ
Teca, Inc.
Neurology · 129d
Cleared Nov 15, 1990
AMI MAMMOSPOT
K903651 · IZH
American Mammographics, Inc.
Radiology · 97d
Cleared Nov 15, 1990
MAMMOSPOT 3 AND MAMMOSPOT 8
K904517 · IZH
American Mammographics, Inc.
Radiology · 43d
Cleared Nov 14, 1990
NONABSORBABLE SILK SURGICAL SUTURE
K904478 · GAP
United States Surgical, A Division of...
General & Plastic Surgery · 47d
Cleared Nov 14, 1990
NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)
K904891 · GAP
United States Surgical, A Division of...
General & Plastic Surgery · 15d
Cleared Nov 13, 1990
THERMAFIL ENDODONTIC OBTURATOR
K900986 · EKM
Tulsa Dental Products, Ltd.
Dental · 257d
Cleared Nov 13, 1990
HILAL EMBOLIZATION MICROCOIL(TM)
K901337 · HCG
Cook, Inc.
Neurology · 236d
Cleared Nov 13, 1990
DENTAL CLEANING RINGS
K902325 · JES
H. Bernath & Assoc.
Dental · 173d
Cleared Nov 13, 1990
CRANIOTOME BLADE OR DRILL BIT
K902703 · HBE
A. Henniss
Neurology · 146d
Cleared Nov 13, 1990
STERILE I.V. START KIT
K902810 · FPA
Orion Life Systems, Inc.
General Hospital · 139d
Cleared Nov 13, 1990
DEVICE PART NUMBER SVD2, 3, 4 SPADE DRILL
K902929 · DZE
Minimatic Implant Technology
Dental · 133d
Cleared Nov 13, 1990
DEVICE PART NUMBER: PD-12 PILOT DRILL
K902931 · DZE
Minimatic Implant Technology
Dental · 131d
Cleared Nov 13, 1990
G.E. POLARIX II C-ARM
K902982 · JAA
Electromek Diagnostic Systems, Inc.
Radiology · 140d
Cleared Nov 13, 1990
AA-1110 ANALOG ABUTMENT
K903042 · DZE
Minimatic Implant Technology
Dental · 125d
Cleared Nov 13, 1990
HS-1113 HEALING SCREW - REV. A
K903062 · DZE
Minimatic Implant Technology
Dental · 127d
Cleared Nov 13, 1990
PART NUMBER: TA-1118 TAP
K903112 · DZE
Minimatic Implant Technology
Dental · 123d
Cleared Nov 13, 1990
PP-1105 PARALLEL PIN
K903114 · DZE
Minimatic Implant Technology
Dental · 123d