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
73993–74016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · MQV
Biomet, Inc.
Orthopedic · 477d
Cleared Sep 06, 2002
ARTHREX UNIVERS FRACTURE PROSTHESIS
K020345 · KWS
Arthrex, Inc.
Orthopedic · 217d
Cleared Sep 06, 2002
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
K021278 · ODG
Pentax Precision Instrument Corp.
Radiology · 137d
Cleared Sep 06, 2002
G-2 VERSION 3, MODEL 10049
K021890 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
G-MOPS, MODEL 10030
K021893 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
G-MM, MODEL 10038
K021894 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
HSA-SOLUTION, MODEL 10034/10064
K021896 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
CALSCOR SOFTWARE
K021913 · LLZ
3D Med Co., Ltd.
Radiology · 87d
Cleared Sep 06, 2002
SYNTHES (USA) RESORBABLE FIXATION SYSTEM
K021928 · JEY
Synthes (Usa)
Dental · 86d
Cleared Sep 06, 2002
ENDOSCOPIC FIBEROPTIC CABLE
K021931 · HBI
Gulf Medical Fiberoptics
General & Plastic Surgery · 86d
Cleared Sep 06, 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932 · HWC
Synthes (Usa)
Orthopedic · 86d
Cleared Sep 06, 2002
THERMIQUE
K022097 · EAT
Parkell, Inc.
Dental · 71d
Cleared Sep 06, 2002
DIRECT BILIRUBIN
K022180 · CIG
Abbott Laboratories
Chemistry · 65d
Cleared Sep 06, 2002
SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
K022229 · OCW
Opus Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Sep 06, 2002
G-1 VERSION 3, MODEL 10048
K022244 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 56d
Cleared Sep 06, 2002
G-FERT, MODEL 10033
K022245 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 56d
Cleared Sep 06, 2002
G-SPERM, MODEL 10032
K022247 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 56d
Cleared Sep 06, 2002
CEREC VITABLOCKS MK2
K022408 · EIH
B.B.'S Prophy Shop
Dental · 44d
Cleared Sep 06, 2002
X-SCRIBE II
K022618 · DPS
Mortara Instrument, Inc.
Cardiovascular · 30d
Cleared Sep 06, 2002
POWDER FREE NITRILE EXAMINATION GLOVES
K022619 · LZA
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 30d
Cleared Sep 06, 2002
KUSKE BREAST APPLICATOR SET, MODEL 189.006
K022635 · JAQ
Nucletron Corporation
Radiology · 29d
Cleared Sep 06, 2002
COOK-SWARTZ DOPPLER FLOW PROBE
K022649 · ITX
Cook Vascular, Inc.
Radiology · 28d
Cleared Sep 06, 2002
LR DICOM CONTROLLER
K022658 · LMC
Agfa Corp.
Radiology · 28d
Cleared Sep 06, 2002
8 CHANNEL CARDIAC PHASED ARRAY COIL
K022669 · MOS
GE Medical Systems
Radiology · 25d