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
71185–71208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2003
APEX ELECTRIC HANDPIECE SYSTEM
K031540 · EKX
Lares Research, Inc.
Dental · 45d
Cleared Jun 30, 2003
FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
K031754 · LYY
Pt. Mandiri Inti Buana
General Hospital · 91d
Cleared Jun 30, 2003
INTERFERENTIAL STIMULATOR, MODEL NETWAVE
K031884 · IPF
Ryan Telemedicine
Physical Medicine · 12d
Cleared Jun 30, 2003
SONOVIEW PRO BY MEDISON CO., LTD.
K031886 · LLZ
Medison Co., Ltd.
Radiology · 12d
Cleared Jun 27, 2003
SMISSON STABILIZATION SYSTEM
K021979 · KWQ
Smisson-Cartledge
Orthopedic · 375d
Cleared Jun 27, 2003
ORIA CLARIS
K023378 · MNH
Ortho Tec, LLC
Orthopedic · 262d
Cleared Jun 27, 2003
RAPID IMF
K030605 · DYX
Zygomatics , Ltd.
Dental · 122d
Cleared Jun 27, 2003
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
K030682 · LYC
Bioform, Inc.
Dental · 114d
Cleared Jun 27, 2003
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090
K030687 · DAP
Kamiya Biomedical Co.
Hematology · 114d
Cleared Jun 27, 2003
BLACKSTONE SURGICAL TITANIUM MESH
K030744 · MQP
Blackstone Medical, Inc.
Orthopedic · 109d
Cleared Jun 27, 2003
WARTNER PRO
K030838 · GEH
Wartner Medical Products
General & Plastic Surgery · 102d
Cleared Jun 27, 2003
EBV VCA-P18 IGG ELISA
K030863 · LSE
Panbio Limited
Microbiology · 101d
Cleared Jun 27, 2003
HI-FLO THERME PNEU 45, WISAP #7083, 7083V
K031014 · HIF
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 88d
Cleared Jun 27, 2003
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
K031023 · HQF
Peregrine Surgical , Ltd.
Ophthalmic · 88d
Cleared Jun 27, 2003
ETI BIPOLAR HEMOSTATIC PROBE
K031026 · KNS
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 27, 2003
YA MEI FIRST AID KIT
K031130 · KGO
Ya Mei Technology Co., Ltd.
General Hospital · 79d
Cleared Jun 27, 2003
ORTHOMEND
K031188 · FTL
Tei Biosciences, Inc.
General & Plastic Surgery · 73d
Cleared Jun 27, 2003
SUSTAIN SPACER
K031302 · MQP
Globus Medical, Inc.
Orthopedic · 64d
Cleared Jun 27, 2003
EBI P148 SPINAL FIXATION SYSTEM
K031423 · MNH
Ebi, L.P.
Orthopedic · 52d
Cleared Jun 27, 2003
BLASTFREEZE AND BLASTTHAW
K031486 · MQL
Medicult A/S
Obstetrics & Gynecology · 46d
Cleared Jun 27, 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K031521 · LPN
Ciba Vision Corporation
Ophthalmic · 43d
Cleared Jun 27, 2003
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K031522 · LPN
Ciba Vision Corporation
Ophthalmic · 43d
Cleared Jun 27, 2003
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
K031538 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 42d
Cleared Jun 27, 2003
U&I, OPTIMA, SPINAL SYSTEM
K031585 · MNH
U&I Corp., America
Orthopedic · 37d