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
80401–80424 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2001
PROFILE-ER
K002331 · DIS
Medtox Diagnostics, Inc.
Toxicology · 169d
Cleared Jan 17, 2001
FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
K002638 · CKG
Future Diagnostics B.V.
Chemistry · 146d
Cleared Jan 17, 2001
ELECSYS DHEA-S
K003174 · JKC
Roche Diagnostics Corp.
Chemistry · 99d
Cleared Jan 17, 2001
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
K003278 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 17, 2001
PHLEBOPUMP, MODEL 1000
K003284 · JOW
Prevent Products, Inc.
Cardiovascular · 90d
Cleared Jan 17, 2001
MAXILLARY DISTRACTOR
K003393 · JEY
Synthes (Usa)
Dental · 77d
Cleared Jan 17, 2001
NC-STAT
K003508 · JXE
Neurometrix, Inc.
Neurology · 64d
Cleared Jan 17, 2001
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
K003556 · JTN
Hardy Diagnostics
Microbiology · 61d
Cleared Jan 17, 2001
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K003575 · LNI
GE Medical Systems
Radiology · 58d
Cleared Jan 17, 2001
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
K003583 · NDW
Trace America, Inc.
Chemistry · 58d
Cleared Jan 17, 2001
HYALURONIDASE REAGENT, MODEL CAT#2212
K003751 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 43d
Cleared Jan 17, 2001
X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING...
K003895 · KGO
Ansell Perry
General Hospital · 30d
Cleared Jan 17, 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
K003901 · DQO
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared Jan 17, 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jan 16, 2001
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
K003745 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 43d
Cleared Jan 16, 2001
ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT...
K003771 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 41d
Cleared Jan 16, 2001
PATTERN RESIN
K003817 · EBG
GC America, Inc.
Dental · 36d
Cleared Jan 16, 2001
CD-CAL PLUS CALIBRATOR
K003991 · KRX
R&D Systems, Inc.
Hematology · 21d
Cleared Jan 12, 2001
2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM
K001259 · DZE
Basic Dental Implant Systems, Inc.
Dental · 268d
Cleared Jan 12, 2001
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
K001775 · DRT
Zoe Medical, Inc.
Cardiovascular · 214d
Cleared Jan 12, 2001
GENUA MENOPAUSE MONITOR TEST KIT
K002450 · CGJ
Genua 1944, Inc.
Chemistry · 156d
Cleared Jan 12, 2001
!NSURE FECAL OCCULT BLOOD TEST
K002457 · KHE
Enterix, Inc.
Hematology · 155d
Cleared Jan 12, 2001
GEON DIGITAL CLINICAL THERMOMETER
K003223 · FLL
Geon Corp.
General Hospital · 88d
Cleared Jan 12, 2001
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · DZE
Lifecore Biomedical, Inc.
Dental · 88d