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
83017–83040 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2000
INSUFFLATION NEEDLE, MODEL R65-933
K000027 · HIF
A & A Medical, Inc.
Obstetrics & Gynecology · 89d
Cleared Apr 03, 2000
ASNIS III CANNULATED SCREW SYSTEM
K000080 · HWC
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Apr 03, 2000
BOHN FEMORAL COMPONENT
K000262 · MEH
Biomet Manufacturing, Inc.
Orthopedic · 66d
Cleared Apr 03, 2000
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
K000459 · DIS
Dade Behring, Inc.
Toxicology · 52d
Cleared Apr 03, 2000
RANDOX FERRITIN
K000662 · DBF
Randox Laboratories, Ltd.
Immunology · 35d
Cleared Apr 03, 2000
OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01
K000797 · JDR
Orthopaedic Biosystems, Ltd.
Orthopedic · 21d
Cleared Apr 03, 2000
WEHRS INCUS-STAPES
K000858 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Apr 03, 2000
RAPIDONE- BARBITURATE TEST
K992451 · DIS
American Bio Medica Corp.
Toxicology · 256d
Cleared Apr 03, 2000
RAPIDONE- BENZODIAZEPINE TEST
K992720 · JXM
American Bio Medica Corp.
Toxicology · 234d
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