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

Filters: Cleared only ×
175,820 results
125929–125952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 06, 1990
LUER LOCK TRANSFER PIN
K901063 · LHI
Acacia, Inc.
General Hospital · 121d
Cleared Jul 06, 1990
CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA
K901074 · DWF
Dlp, Inc.
Cardiovascular · 120d
Cleared Jul 06, 1990
HOLLOW MOTOR DRIVE UNIT
K901601 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 91d
Cleared Jul 06, 1990
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625 · DXE
Baxter Healthcare Corp
Cardiovascular · 88d
Cleared Jul 06, 1990
APPLIED VASCULAR DEVICES 6MM TRACTION CLIP
K901628 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 88d
Cleared Jul 06, 1990
RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT
K901672 · EIA
Pelton & Crane Co.
Dental · 87d
Cleared Jul 06, 1990
CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE
K901691 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
Cleared Jul 06, 1990
GE SIGNA ADVANTAGE
K901730 · LNH
GE Medical Systems
Radiology · 81d
Cleared Jul 06, 1990
EQUI-GUARD (ASPIRATOR FILTER)
K902089 · GCX
Equi-Tron Mfg., Inc.
General Hospital · 58d
Cleared Jul 06, 1990
MODIFIED EPICARDIAL ARRAY
K902228 · DRF
C.R. Bard, Inc.
Cardiovascular · 50d