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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
125329–125352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1990
EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2
K902578 · DKB
Syva Co.
Toxicology · 29d
Cleared Jul 10, 1990
MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS
K902635 · EMA
Confi-Dental Products Co.
Dental · 28d
Cleared Jul 10, 1990
ATAC 6000 CHEMISTRY ANALYZER
K902689 · JJE
Bio-Chem Laboratories
Chemistry · 21d
Cleared Jul 10, 1990
IMX ULTRASENTITIVE HTSH
K902753 · JLW
Abbott Mfg., Inc.
Chemistry · 18d
Cleared Jul 10, 1990
TACTYLON TM SURGICAL GLOVE
K902831 · KGO
Tactyl Technologies, Inc.
General Hospital · 12d
Cleared Jul 09, 1990
TFV-2300 INFUSION PUMP
K890736 · FRN
Nihon Kohden America, Inc.
General Hospital · 511d
Cleared Jul 09, 1990
SONICAID MODEL VASOFLO 4
K895909 · MAA
Oxford Medilog, Inc.
Radiology · 272d
Cleared Jul 09, 1990
BABY BOARDS IV SUPPORT ASSEMBLY
K900134 · KMK
Baby Boards, Inc.
General Hospital · 180d
Cleared Jul 09, 1990
ULTRASOUND SCANNER MODEL #1150
K900469 · IYO
Pie Medical USA BV
Radiology · 159d
Cleared Jul 09, 1990
CYANODONT DENTAL CEMENT
K901082 · EMA
Specialites Septodont
Dental · 124d
Cleared Jul 09, 1990
F.G. LASER (DENTAL BUR)
K901262 · DZP
Diamond Rotary and Carbide Intl.
Dental · 115d
Cleared Jul 09, 1990
CVIS INSIGHT IMAGING CATHETER
K901562 · DXK
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 97d
Cleared Jul 09, 1990
NARKOMED 4 ANESTHESIA SYSTEM
K901713 · BSZ
Draeger Medical, Inc.
Anesthesiology · 87d
Cleared Jul 09, 1990
GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415
K901832 · KGI
Amersham Corp.
Radiology · 76d
Cleared Jul 09, 1990
GADOLINIUM-153 BONE DENSITOMETER SOURCES
K901848 · KGI
Amersham Corp.
Radiology · 76d
Cleared Jul 09, 1990
GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)
K901854 · KGI
Amersham Corp.
Radiology · 76d
Cleared Jul 09, 1990
GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)
K901857 · KGI
Amersham Corp.
Radiology · 76d
Cleared Jul 09, 1990
MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT
K902237 · DBL
Medica Corp.
Immunology · 52d
Cleared Jul 09, 1990
CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P
K902559 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Jul 09, 1990
ADAM MARK II CUSTOM IN-THE-EAR HEARING AID
K902570 · ESD
Adams Hearing Aid Center
Ear, Nose, Throat · 31d
Cleared Jul 09, 1990
FALCON DISK DRIVE SUBSYSTEM
K902643 · JAK
Sokar, Inc.
Radiology · 24d
Cleared Jul 06, 1990
SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR
K895145 · JWH
Orthomet, Inc.
Orthopedic · 322d
Cleared Jul 06, 1990
BIRD MICROBLENDER M.R.I.
K895695 · BZR
Bird Products Corp.
Anesthesiology · 288d
Cleared Jul 06, 1990
GC CERVICAL CEMENT
K896883 · EMA
G-C Intl. Corp.
Dental · 210d