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
139513–139536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1987
OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C
K871207 · DXN
Omron Electronics, Inc.
Cardiovascular · 64d
Cleared May 28, 1987
SYPHILIS SEROLOGICAL REAGENTS
K871226 · GMQ
New Horizons Diagnostics Co.
Microbiology · 62d
Cleared May 28, 1987
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS
K871484 · LGS
Roche Diagnostic Systems, Inc.
Chemistry · 43d
Cleared May 28, 1987
TRU-SOUND ULTRASOUND THERAPY UNIT
K871633 · IMJ
Tru-Trac Therapy Products, Inc.
Physical Medicine · 31d
Cleared May 28, 1987
IMS-2000S STRESS MONITOR
K871659 · DXG
Integrated Medical Systems, Inc.
Cardiovascular · 30d
Cleared May 28, 1987
LD PRESUMPTO QUAD
K871907 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 13d
Cleared May 27, 1987
CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D
K863969 · DXO
Camino Laboratories, Inc.
Cardiovascular · 225d
Cleared May 27, 1987
TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT
K870412 · DQY
Medical Surgical Concepts, Inc.
Cardiovascular · 113d
Cleared May 27, 1987
CANNULATED INSTRUMENT CLEANERS
K870765 · EKW
Treace Medical, Inc.
Dental · 90d
Cleared May 27, 1987
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
K870805 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 85d
Cleared May 27, 1987
SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP
K870842 · HTP
Warsaw Orthopedic, Inc.
Orthopedic · 85d
Cleared May 27, 1987
SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA
K870843 · HWT
Warsaw Orthopedic, Inc.
Orthopedic · 85d
Cleared May 27, 1987
IV START KIT
K871281 · LRS
The Jarid Group, Inc.
General & Plastic Surgery · 57d
Cleared May 27, 1987
ADVANCED MEDICAL SYSTEMS, KIT
K871322 · LRO
The Jarid Group, Inc.
General & Plastic Surgery · 54d
Cleared May 27, 1987
MODIFIED PROFILE HIP PMMA CEMENT SPACER
K871510 · JDI
Depuy, Inc.
Orthopedic · 42d
Cleared May 27, 1987
CARERITE BIOPACK GINGIVAL RETRACTION CORD
K871736 · JES
Cost Rite Health Products, Inc.
Dental · 22d
Cleared May 27, 1987
CREATININE STANDARD SOLUTION CALIBRATOR
K871756 · JIT
Wako Chemicals USA, Inc.
Chemistry · 22d
Cleared May 27, 1987
TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI
K871784 · KMT
Colgate-Hoyt Laboratories
Dental · 21d
Cleared May 27, 1987
COMPOSITE RESTORATIVE CARRIER
K871909 · EIY
Dentsply Intl.
Dental · 9d
Cleared May 26, 1987
GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA
K864282 · CGA
Medical Device Consultants, Inc.
Chemistry · 208d
Cleared May 26, 1987
SKIN GRAFT PRESERVATION MEDIUM (TISSUE)
K870451 · KIT
Bioclinical Laboratory Services, Inc.
Pathology · 112d
Cleared May 26, 1987
ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT
K870572 · JOL
Arrow Intl., Inc.
General Hospital · 105d
Cleared May 26, 1987
NOILES TOTAL KNEE PROSTHESIS
K870730 · JWH
Joint Medical Products Corp.
Orthopedic · 90d
Cleared May 26, 1987
COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.
K870733 · GQN
Enzo Biochem, Inc.
Microbiology · 90d