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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39649–39672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2013
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
K132626 · LPH
Pipeline Biotechnology
Orthopedic · 28d
Cleared Sep 19, 2013
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
K132632 · MBI
Tornier, Inc.
Orthopedic · 28d
Cleared Sep 19, 2013
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT...
K132644 · MNI
Corentec Co., Ltd.
Orthopedic · 24d
Cleared Sep 18, 2013
GC-3000E DIGITAL COLPOSCOPE
K122311 · HEX
Shenzhen Goldcare Meditech Co., Ltd.
Obstetrics & Gynecology · 413d
Cleared Sep 18, 2013
ALPHA-PRO WHITE VARNISH
K124025 · LBH
Dental Technologies, Inc.
Dental · 264d
Cleared Sep 18, 2013
NAVIOS FLOW CYTOMETER SYSTEM
K130373 · OYE
Beckman Coulter, Inc.
Hematology · 216d
Cleared Sep 18, 2013
SMARTBUILDER SYSTEM (SB1)
K130840 · JEY
Osstem Implant Co., Ltd.
Dental · 175d
Cleared Sep 18, 2013
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K131122 · OVD
Renovis Surgical Technologies, LLC
Orthopedic · 149d
Cleared Sep 18, 2013
TRANSTEK GLASS BODY FAT ANALYZER
K131394 · MNW
Guangdong Transtek Medical...
Gastroenterology & Urology · 126d
Cleared Sep 18, 2013
MEDLINE ANTI-REFLUX VALVE
K132314 · FEG
Medline Industries, Inc.
Gastroenterology & Urology · 55d
Cleared Sep 17, 2013
CREODENT SOLIDEX CUSTOM ABUTMENT
K113738 · NHA
Creodent Prosthetics, Ltd.
Dental · 637d
Cleared Sep 17, 2013
VCARE A
K121817 · OMP
IVT Medical, Ltd.
General & Plastic Surgery · 454d
Cleared Sep 17, 2013
FACIAL SPA
K122711 · NFO
Nuskin
Neurology · 378d
Cleared Sep 17, 2013
ANSWATCH WRIST MONITOR MODEL TS-0411
K123130 · DXN
Taiwan Scientific Corporation
Cardiovascular · 348d
Cleared Sep 17, 2013
ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
K130232 · DXN
Jinxinbao Electronic Co.,Ltd
Cardiovascular · 231d
Cleared Sep 17, 2013
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
K130595 · HSB
Zimmer, Inc.
Orthopedic · 194d
Cleared Sep 17, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR
K131114 · MQB
Rayence Co., Ltd.
Radiology · 148d
Cleared Sep 17, 2013
EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER
K131161 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 146d
Cleared Sep 17, 2013
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
K131745 · LFB
Helix Medical, LLC
Ear, Nose, Throat · 96d
Cleared Sep 17, 2013
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K131830 · IYO
Edan Instruments, Inc.
Radiology · 89d
Cleared Sep 17, 2013
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
K131977 · LLZ
Ge Healthcare
Radiology · 81d
Cleared Sep 17, 2013
ABL90 FLEX ANALYZER
K131988 · CHL
Radiometer Medical Aps
Chemistry · 81d
Cleared Sep 17, 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 67d
Cleared Sep 17, 2013
5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION...
K132590 · MBI
ArthroCare Corporation
Orthopedic · 29d