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
77209–77232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2001
ICE
K012528 · EBF
Southern Dental Industries, Ltd.
Dental · 77d
Cleared Oct 22, 2001
ROK
K012529 · EBF
Southern Dental Industries, Ltd.
Dental · 77d
Cleared Oct 22, 2001
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
K012625 · GEI
Alliance Medical Corp.
General & Plastic Surgery · 70d
Cleared Oct 22, 2001
NAVIGUS II MR
K012719 · HAW
Image-Guided Neurologics, Inc.
Neurology · 69d
Cleared Oct 22, 2001
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K012777 · JZO
Bayer Corp.
Immunology · 63d
Cleared Oct 22, 2001
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
K012821 · HRN
Dutch Ophthalmic USA, Inc.
Ophthalmic · 60d
Cleared Oct 22, 2001
COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER
K012955 · NEU
Bioform, Inc.
General & Plastic Surgery · 48d
Cleared Oct 22, 2001
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
K013059 · GAQ
Stony Brook Surgical Innovations, Inc.
General & Plastic Surgery · 41d
Cleared Oct 22, 2001
BIOSCANNER PLUS
K013173 · CHH
Polymer Technology Systems, Inc.
Chemistry · 28d
Cleared Oct 22, 2001
STATUSBLUE
K013237 · ELW
Dmg USA, Inc.
Dental · 24d
Cleared Oct 22, 2001
ASTRALIS 7, MODEL 557545
K013277 · EBZ
Ivoclar Vivadent, Inc.
Dental · 20d
Cleared Oct 19, 2001
RIWO SYSTEM TRAYS
K012309 · FEB
Richard Wolf Medical Instruments Corp.
General Hospital · 88d
Cleared Oct 19, 2001
POWERPRO BATTERY SYSTEM
K012320 · HAB
Linvatec Corp.
General & Plastic Surgery · 88d
Cleared Oct 19, 2001
AML HIP PROSTHESIS
K012364 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Oct 19, 2001
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
K012510 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 74d
Cleared Oct 19, 2001
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016 · LZA
Tillotson Healthcare Corp.
General Hospital · 42d
Cleared Oct 19, 2001
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6...
K013135 · DHB
Diagnostic Products Corp.
Immunology · 30d
Cleared Oct 19, 2001
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
MARK II/MARK III MANOMETRIC PERFUSION PUMP
K013154 · FFX
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K013156 · MSX
Data Critical Corp.
Cardiovascular · 28d
Cleared Oct 19, 2001
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH...
K013162 · KNT
Medcomp
Gastroenterology & Urology · 28d
Cleared Oct 19, 2001
ASTRALIS 10, MODELS # 559588, 561859
K013275 · EBZ
Ivoclar Vivadent, Inc.
Dental · 18d
Cleared Oct 19, 2001
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K013356 · FCG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 9d