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
102913–102936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1995
HEMA-GLU
K951220 · KLE
Health-Dent Intl., Inc.
Dental · 53d
Cleared May 12, 1995
RELACS 7000
K951272 · ELC
Micro-Mega Societe Anonyme
Dental · 52d
Cleared May 12, 1995
AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL...
K951426 · EBF
American Dental Products, Inc.
Dental · 45d
Cleared May 12, 1995
TREBAY IRRGATED CUTTER BLADE
K951526 · EQJ
Trebay Medical Corp.
Ear, Nose, Throat · 39d
Cleared May 12, 1995
PROSYS URIHESIVE SYSTEM LA
K951530 · EXJ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 39d
Cleared May 12, 1995
PERMAQUIK BONDING PRIMER
K951583 · KLE
Ultradent Products, Inc.
Dental · 36d
Cleared May 12, 1995
MIST ENDOSCOPIC NEEDLES
K951648 · FBK
Mist, Inc.
Gastroenterology & Urology · 32d
Cleared May 12, 1995
OPERAND* ULTRASOUND TRANSMISSION GEL
K951695 · IYN
Redi Products, Inc.
Radiology · 30d
Cleared May 12, 1995
FMS HIGH FLOW ARTHRO-SHEATH
K951702 · HNX
Future Medical Systems, Inc.
Ophthalmic · 30d
Cleared May 12, 1995
ENDO IRRIGATOR 2211, INCLUDING TUBING
K951715 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 29d
Cleared May 12, 1995
AVANTGARDE
K951847 · IOR
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 22d
Cleared May 12, 1995
DISOPOSABLE & RESUABLE MONPOLAR CORD
K951912 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 18d
Cleared May 11, 1995
NURTURE III
K924312 · HGX
Bailey Medical Engineering
Obstetrics & Gynecology · 988d
Cleared May 11, 1995
THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE
K932149 · HIR
Thought Technology , Ltd.
Gastroenterology & Urology · 737d
Cleared May 11, 1995
INCONTROL
K935213 · HIR
Thought Technology , Ltd.
Gastroenterology & Urology · 559d
Cleared May 11, 1995
PW DOPPLER VASCULAR PROBES
K935994 · ITX
Koven Technology, Inc.
Radiology · 512d
Cleared May 11, 1995
SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES
K936236 · JAA
Shimadzu Medical Systems
Radiology · 497d
Cleared May 11, 1995
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
K940209 · GGN
Ortho Diagnostic Systems, Inc.
Hematology · 482d
Cleared May 11, 1995
QCT-BONE MINERAL ANALYSIS SOFTWARE
K941127 · KGI
Image Analysis, Inc.
Radiology · 428d
Cleared May 11, 1995
REAL TIME STEREOTIX
K941191 · IZH
GE Medical Systems
Radiology · 423d
Cleared May 11, 1995
OP-PNEU ELECTRONIC CO2
K941438 · HIF
Wisap/U.S.A.
Obstetrics & Gynecology · 413d
Cleared May 11, 1995
COAGUCHEK SYSTEM
K942884 · GJS
Boehringer Mannheim Corp.
Hematology · 328d
Cleared May 11, 1995
PS II
K943513 · LYR
Washington Biotechnology
Microbiology · 295d
Cleared May 11, 1995
STACLOT HEPARIN TEST KIT
K943517 · KFF
American Bioproducts Co.
Hematology · 294d