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
131449–131472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1989
SURGICAL DRILLS
K891615 · DZE
Implant Innovations International, Inc.
Dental · 28d
Cleared Apr 17, 1989
TITANIUM FORCEPS
K891618 · DZE
Implant Innovations International, Inc.
Dental · 28d
Cleared Apr 17, 1989
BICARBONATE CONCENTRATE POWDER
K891921 · KPO
Haemolyte, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 14, 1989
FETAL DOPPLER FOR ULTRAMARK 4 AND 8
K881329 · HEM
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 380d
Cleared Apr 14, 1989
H&M ANTI-SNORING DEVICE
K882303 · LRK
Hays & Meade, Inc.
Dental · 315d
Cleared Apr 14, 1989
CESIUM 137 SOURCE, MODEL CSM-40
K882449 · IWI
Cis-Us, Inc.
Radiology · 304d
Cleared Apr 14, 1989
ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR
K883609 · FRN
Squibb Diagnostics
Radiology · 235d
Cleared Apr 14, 1989
COMFORTRON DENTAL ANESTHESIA APPARATUS
K884586 · LWM
M. D. Products
Dental · 163d
Cleared Apr 14, 1989
APEX 215M MOBILE ANGER CAMERA
K884673 · IYX
Elscint, Inc.
Radiology · 157d
Cleared Apr 14, 1989
BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING
K884937 · EEG
Grass-Telefactor Product Group
Dental · 137d
Cleared Apr 14, 1989
ANA-5 AUTOANTIBODY PROFILE KIT
K885224 · LKJ
Autoimmunity Diagnostics Corp.
Immunology · 115d
Cleared Apr 14, 1989
INTERSPEC APOGEE
K890173 · IYO
Interspec, Inc.
Radiology · 87d
Cleared Apr 14, 1989
REDI-VU MODEL RV-386
K890397 · LLZ
J.D. Technical Services
Radiology · 80d
Cleared Apr 14, 1989
WANG FRONT LOADING APPLICATOR
K890485 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 73d
Cleared Apr 14, 1989
TRANSCUTANEOUS O2/CO2 MONITOR
K890517 · LKD
Novametrix Medical Systems, Inc.
Anesthesiology · 74d
Cleared Apr 14, 1989
MODEL 3031
K890666 · LNH
Medical Advances, Inc.
Radiology · 64d
Cleared Apr 14, 1989
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831 · KLI
Syva Co.
Chemistry · 52d
Cleared Apr 14, 1989
AQUA-BLANKET HYPER/HYPOHERMIA BLANKET
K890852 · ILO
Ati
Physical Medicine · 52d
Cleared Apr 14, 1989
AQUA-PAD FOR MOIST OR DRY HEAT THERAPY
K890853 · ILO
Ati
Physical Medicine · 52d
Cleared Apr 14, 1989
SURGICAL GOWN #2001
K891211 · FYA
Pro-Safe Professional Linens, Inc.
General Hospital · 38d
Cleared Apr 14, 1989
APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE
K891212 · FXO
Pro-Safe Professional Linens, Inc.
General Hospital · 38d
Cleared Apr 14, 1989
SURGICAL INSTRUMENT POUCH #M102
K891213 · KCT
Pro-Safe Professional Linens, Inc.
General Hospital · 38d
Cleared Apr 14, 1989
DENTAL SURGICAL WRAP #3007 A,B,C
K891214 · KCT
Pro-Safe Professional Linens, Inc.
General Hospital · 38d
Cleared Apr 14, 1989
FAST WRAP #M 101
K891215 · KCT
Pro-Safe Professional Linens, Inc.
General Hospital · 38d