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
82513–82536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2000
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
K992918 · DKZ
OraSure Technologies, Inc.
Toxicology · 217d
Cleared Apr 03, 2000
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
K993208 · LAF
OraSure Technologies, Inc.
Toxicology · 192d
Cleared Apr 03, 2000
WAKO L-TYPE UN TEST
K993925 · CDQ
Wako Chemicals USA, Inc.
Chemistry · 137d
Cleared Mar 31, 2000
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
K000026 · HHK
Apple Medical Corp.
Obstetrics & Gynecology · 86d
Cleared Mar 31, 2000
CORTEK LAPAROSCOPES
K000202 · GCJ
Cortek Endoscopy, Inc.
General & Plastic Surgery · 70d
Cleared Mar 31, 2000
HARDYDISK, CEFOXITIN, 30MCG
K000305 · JTN
Hardy Diagnostics
Microbiology · 59d
Cleared Mar 31, 2000
S57D DIGITAL OPERATING ROOM CAMERA
K000422 · GCJ
Sopro
General & Plastic Surgery · 51d
Cleared Mar 31, 2000
S52D DIGITAL VIDEO LAPAROSCOPE
K000423 · GCJ
Sopro
General & Plastic Surgery · 51d
Cleared Mar 31, 2000
S51D DIGITAL ENDOSCOPY CAMERA
K000424 · GCJ
Sopro
General & Plastic Surgery · 51d
Cleared Mar 31, 2000
DIMEX 2
K000454 · MUH
Planmeca Oy
Radiology · 49d
Cleared Mar 31, 2000
RANDOX ALBUMIN
K000483 · CJW
Randox Laboratories, Ltd.
Chemistry · 46d
Cleared Mar 31, 2000
ENVOY AND VISTA BRITE TIP
K000715 · DQY
Cordis Corp.
Cardiovascular · 29d
Cleared Mar 31, 2000
UNIPOLAR NEEDLES
K000722 · BSP
Pajunk GmbH
Anesthesiology · 28d
Cleared Mar 31, 2000
MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
K000731 · HLI
Talia Technology , Ltd.
Ophthalmic · 25d
Cleared Mar 31, 2000
HYDROCISION DEBDRIDEMENT SYSTEM
K991383 · FQH
Hydrocision, Inc.
General Hospital · 345d
Cleared Mar 31, 2000
RTLX
K992392 · MUH
Infimed, Inc.
Radiology · 256d
Cleared Mar 31, 2000
BITX PROBES
K993412 · GEI
Everest Medical Corp.
General & Plastic Surgery · 171d
Cleared Mar 31, 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K993512 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 165d
Cleared Mar 31, 2000
ISOSEED PD-103
K993552 · KXK
Bebig Isotopentechnik GmbH
Radiology · 163d
Cleared Mar 30, 2000
BRANEMARK NOVUM
K000018 · DZE
Nobel Biocare Uas, Inc.
Dental · 86d
Cleared Mar 30, 2000
LEVEEN NEEDLE ELECTRODE
K000032 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 85d
Cleared Mar 30, 2000
MONOFILAMENT BIOSYN SUTURE
K000037 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 84d
Cleared Mar 30, 2000
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
K000046 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 83d
Cleared Mar 30, 2000
VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5
K000369 · FMI
Medpro Technologies, Inc.
General Hospital · 55d