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
139369–139392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1987
CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
K871801 · DHN
Cytotech, Inc.
Immunology · 32d
Cleared Jun 09, 1987
UNIMED SURGEON'S GOWNS
K871906 · FYA
Unimed Hospital Supply Corp.
General Hospital · 25d
Cleared Jun 09, 1987
GRASPING FORCEP, 1.7MM
K871926 · GEN
Arthropedics, Inc.
General & Plastic Surgery · 22d
Cleared Jun 09, 1987
CUP BIOPSY FORCEP, 1.7MM
K871927 · GEN
Arthropedics, Inc.
General & Plastic Surgery · 22d
Cleared Jun 09, 1987
TOURNIQUET PRESSURE REGULATOR
K871982 · KCY
Avec Scientific Design Corp.
General & Plastic Surgery · 18d
Cleared Jun 08, 1987
ACCUDENT ACCUPROBE
K870280 · EIX
Accudent, Inc.
Dental · 132d
Cleared Jun 08, 1987
DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)
K870405 · CHP
Diagnostic Systems Laboratories, Inc.
Chemistry · 125d
Cleared Jun 08, 1987
BUBBLE TRAP CAT. NO. B-180
K870819 · DWF
American Omni Medical, Inc.
Cardiovascular · 97d
Cleared Jun 08, 1987
OMEGA NASAL SEPTAL BUTTON
K871072 · LFB
Omega Silicone, Inc.
Ear, Nose, Throat · 82d
Cleared Jun 08, 1987
MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.
K871199 · BTO
Frederic J. Toye, M.D.
Anesthesiology · 75d
Cleared Jun 08, 1987
VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA
K871300 · HIS
Professional Pharmacy West, Inc.
Obstetrics & Gynecology · 68d
Cleared Jun 08, 1987
BOWEN REUSEABLE/DISPOSABLE ELECTRODE
K871325 · DRX
Bowen & Company, Inc.
Cardiovascular · 66d
Cleared Jun 08, 1987
PREBYPASS FILTER
K871350 · KRJ
American Omni Medical, Inc.
Cardiovascular · 63d
Cleared Jun 08, 1987
OXIMETER
K871353 · DQA
Radiometer America, Inc.
Anesthesiology · 63d
Cleared Jun 08, 1987
COSMETIC SINGLE SPAN BRIDGE
K871439 · EGG
Cosmetic Dental Technologies, Inc.
Dental · 56d
Cleared Jun 08, 1987
TELSTAR MODEL FS HEARING AID
K871520 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 49d
Cleared Jun 08, 1987
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
K871569 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 45d
Cleared Jun 08, 1987
TMJ CANNULA SET
K871648 · DZI
Aspen Laboratories, Inc.
Dental · 41d
Cleared Jun 08, 1987
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
K871680 · LAN
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Jun 08, 1987
RIBBED CUSHION MASK
K871851 · BSJ
Engineered Medical Systems
Anesthesiology · 27d
Cleared Jun 08, 1987
ESKA-HERRMANN TRACHEOSTOMY VALVE
K871885 · EWL
C.R. Bard, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 08, 1987
BTE HEARING AID OTICON MODEL E30P
K872017 · ESD
Oticon Corp.
Ear, Nose, Throat · 13d
Cleared Jun 05, 1987
TRI-SERVICE OMV VAPORIZER
K864589 · BSZ
Bear Medical Systems, Inc.
Anesthesiology · 196d
Cleared Jun 05, 1987
DORROS(TM) SMALL VESSEL PTA CATHETER
K870460 · DXN
C.R. Bard, Inc.
Cardiovascular · 122d