FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74233–74256 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2002
MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650
K022210 · MKJ
Cardiac Science, Inc.
Cardiovascular · 88d
Cleared Oct 04, 2002
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006...
K022257 · DRC
Vomed Volzer Medizintechnik GmbH & Co.
Cardiovascular · 84d
Cleared Oct 04, 2002
KOKOMATE
K022276 · BZG
Ferraris Respiratory, Inc.
Anesthesiology · 81d
Cleared Oct 04, 2002
RHINOSTREAM RHINOMANOMETER MODULE
K022311 · BXQ
Rhino Metrics A/S
Anesthesiology · 79d
Cleared Oct 04, 2002
RHS ACETABULAR COMPONENT
K022382 · LPH
Signal Medical Corp.
Orthopedic · 74d
Cleared Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021 · HWC
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Oct 04, 2002
NUGEN FX SCREW
K023022 · HWC
Bionx Implants, Inc.
Orthopedic · 23d
Cleared Oct 04, 2002
SYNCHRON LX I 725 CLINICAL SYSTEM
K023049 · JGS
Beckman Coulter, Inc.
Chemistry · 22d
Cleared Oct 04, 2002
CLASSIC GREAT TOE IMPLANT
K023086 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 17d
Cleared Oct 04, 2002
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
K023124 · MQB
Canon, Inc.
Radiology · 15d
Cleared Oct 03, 2002
INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES
K020334 · GEI
Jac-Cell Medic Corporation
General & Plastic Surgery · 245d
Cleared Oct 03, 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
K020810 · DAP
bioMerieux, Inc.
Hematology · 204d
Cleared Oct 03, 2002
RADIANALYZER, MODEL 12710
K022188 · DQK
Radi Medical Systems AB
Cardiovascular · 90d
Cleared Oct 03, 2002
DISPOSABLE N-PE MICROKERATOME BLADES
K022205 · HNO
Oasis Medical, Inc.
Ophthalmic · 90d
Cleared Oct 03, 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
K022234 · HWC
Arthrex, Inc.
Orthopedic · 84d
Cleared Oct 03, 2002
AURORA SR
K022266 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 83d
Cleared Oct 03, 2002
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT...
K022300 · ELM
Dental Vipi Ltda
Dental · 79d
Cleared Oct 03, 2002
MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE...
K022475 · GEI
Arthrocare Corp.
General & Plastic Surgery · 66d
Cleared Oct 03, 2002
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
K022485 · MHX
Datex-Ohmeda
Cardiovascular · 66d
Cleared Oct 03, 2002
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN...
K022808 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 41d
Cleared Oct 03, 2002
CSV12 SOFTWARE VIEWER
K022896 · LLZ
Acuson Corp.
Radiology · 30d
Cleared Oct 03, 2002
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION...
K022904 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 30d
Cleared Oct 03, 2002
QSC-63-INT SHOULDER ARRAY COIL SET
K022910 · MOS
Mri Devices Corp.
Radiology · 30d
Cleared Oct 03, 2002
OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND...
K022939 · DTE
Osypka Medical, Inc.
Cardiovascular · 29d