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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73969–73992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2002
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
K022831 · LZG
Disetronic Medical Systems AG
General Hospital · 16d
Cleared Sep 11, 2002
MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
K022875 · JKA
Becton, Dickinson & CO
Chemistry · 12d
Cleared Sep 11, 2002
MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
K022876 · FPL
International Biomedical, Inc.
General Hospital · 12d
Cleared Sep 10, 2002
WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER...
K021334 · CJY
Wiener Laboratories Saic
Chemistry · 137d
Cleared Sep 10, 2002
UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
K021623 · MNH
Iame, Inc.
Orthopedic · 117d
Cleared Sep 10, 2002
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
K021929 · LFL
Axya Medical, Inc.
General & Plastic Surgery · 90d
Cleared Sep 10, 2002
MEDX LCS LASER SERIES
K021985 · NHN
Medx Electronics, Inc.
Physical Medicine · 84d
Cleared Sep 10, 2002
XLTEK SLEEP SYSTEM
K022037 · OLV
Excel Tech. , Ltd.
Neurology · 78d
Cleared Sep 10, 2002
DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB...
K022104 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 74d
Cleared Sep 10, 2002
AVAGEN WOUND DRESSING
K022127 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 71d
Cleared Sep 10, 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP...
K022158 · CGA
Instrumentation Laboratory CO
Chemistry · 70d
Cleared Sep 10, 2002
NORMED MINI EXTERNAL FIXATOR SYSTEM
K022230 · HRS
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 10, 2002
PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
K022664 · GAM
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 32d
Cleared Sep 10, 2002
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
K022782 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 19d
Cleared Sep 09, 2002
ACT III VENTRICULAR CATHETER
K013705 · GWM
Innerspace, Inc.
Neurology · 305d
Cleared Sep 09, 2002
IPLAN
K020631 · HAW
Brainlab AG
Neurology · 194d
Cleared Sep 09, 2002
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
K020972 · DHR
Wako Chemicals USA, Inc.
Immunology · 167d
Cleared Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
K021218 · JFT
Roche Diagnostics Corp.
Chemistry · 145d
Cleared Sep 09, 2002
P4 PHYSIO
K022175 · IPF
Valmed Corp.
Physical Medicine · 68d
Cleared Sep 09, 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM...
K022182 · NBW
Abbott Laboratories
Chemistry · 68d
Cleared Sep 09, 2002
CRANIAL SYMMETRY SYSTEM
K022273 · MVA
Beverly Hills Prosthetics Orthotics,...
Neurology · 56d
Cleared Sep 09, 2002
NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
K022323 · HRS
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 09, 2002
NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
K022325 · HRS
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 09, 2002
BENJAMIN ENVOY PHACO HANDPIECE
K022833 · HQC
Benjamin Biomedical, Inc.
Ophthalmic · 14d