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
37441–37464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2014
0180 INTUITION, 0072 PRECISION
K140683 · KPR
Arcoma AB
Radiology · 77d
Cleared Jun 03, 2014
BIOMET CANNULATED SCREW SYSTEM
K140891 · HWC
Biomet, Inc.
Orthopedic · 56d
Cleared Jun 03, 2014
RANGE SPINAL SYSTEM
K141147 · NKB
K2m, Inc.
Orthopedic · 29d
Cleared Jun 02, 2014
LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM
K132016 · ILY
Texas Applied Biomedical Services, Inc.
Physical Medicine · 336d
Cleared Jun 02, 2014
POWDER FREE POLYETHYLENE EXAMINATION GLOVES
K133478 · LZA
Shijiazhuang Hongzan Plastic...
General Hospital · 202d
Cleared Jun 02, 2014
VIRAGE OCT SPINAL FIXATION SYSTEM
K133556 · KWP
Zimmer Spine, Inc.
Orthopedic · 195d
Cleared Jun 02, 2014
CHOCOLATE PTCA BOLLOON CATHETER
K133633 · LOX
Trireme Medical, Inc.
Cardiovascular · 188d
Cleared Jun 02, 2014
SCHOELLY ARTHROSCOPE
K133682 · HRX
Scholly Fiberoptic GmbH
Orthopedic · 182d
Cleared Jun 02, 2014
ARIA WIFI SMART SCALE
K133872 · MNW
Fitbit, Inc.
Gastroenterology & Urology · 164d
Cleared Jun 02, 2014
ASPIRON ACP SYSTEM
K140234 · KWQ
U&I Corp.
Orthopedic · 124d
Cleared Jun 02, 2014
BRIGHTMATTER PLANNING SOFTWARE
K140337 · LLZ
Synaptive Medical, Inc.
Radiology · 112d
Cleared Jun 02, 2014
COMPRESSYN STAPLE
K140358 · JDR
Dallen Medical, Inc.
Orthopedic · 110d
Cleared Jun 02, 2014
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND...
K140364 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 110d
Cleared Jun 02, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)
K140468 · LON
Becton, Dickinson and Company
Microbiology · 97d
Cleared Jun 02, 2014
TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
K140774 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 66d
Cleared May 30, 2014
DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
K123940 · GAM
Demetech Corp.
General & Plastic Surgery · 526d
Cleared May 30, 2014
LMA FAMILY OF AIRWAYS
K130304 · CAE
The Laryngeal Mask Co., Ltd.
Anesthesiology · 477d
Cleared May 30, 2014
T1/T2/T3 TURBINE FAMILY
K131319 · EFB
Sirona Dental Systems GmbH
Dental · 388d
Cleared May 30, 2014
A-TONE IPL SYSTEM
K131712 · ONF
Ybk Investment, Inc.
General & Plastic Surgery · 353d
Cleared May 30, 2014
FAMILY HEALTHWARE
K132173 · DRG
Sanitas, Inc.
Cardiovascular · 319d
Cleared May 30, 2014
X-MIND UNITY
K132378 · EHD
De Gotzen S.R.L.
Radiology · 303d
Cleared May 30, 2014
BIO-PROBE DISPOSABLE INSERT WITH
K132730 · DPT
Medtronic, Inc.
Cardiovascular · 269d
Cleared May 30, 2014
NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F
K133123 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 242d
Cleared May 30, 2014
ULTRAPRO COMFORT PLUG
K133198 · FTL
Ethicon, Inc.
General & Plastic Surgery · 225d