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
84361–84384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1999
MBA
K993057 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Oct 05, 1999
ALCYON 300I (WITH ISE MODULE) ANALYZER
K993083 · CEM
Abbott Laboratories
Chemistry · 20d
Cleared Oct 05, 1999
ASCENT KNEE SYSTEM
K993111 · JWH
Biomet Manufacturing, Inc.
Orthopedic · 18d
Cleared Oct 04, 1999
CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
K991531 · DRF
Cordis Webster, Inc.
Cardiovascular · 154d
Cleared Oct 04, 1999
CARDIOQUANT TROPONIN I TEST
K992127 · MMI
Spectral Diagnostics, Inc.
Chemistry · 103d
Cleared Oct 04, 1999
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
K992262 · KXK
Indigo Medical, Inc.
Radiology · 90d
Cleared Oct 04, 1999
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR
K992466 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 73d
Cleared Oct 04, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
K993068 · JHX
Ortho-Clinical Diagnostics
Chemistry · 21d
Cleared Oct 04, 1999
GENZYME DIRECT AMYLASE VERIFIER
K993132 · JIT
Genzyme Corp.
Chemistry · 14d
Cleared Oct 01, 1999
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
K990276 · KRJ
Porous Media Corp.
Cardiovascular · 246d
Cleared Oct 01, 1999
T-ANASTAFLO
K990396 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 234d
Cleared Oct 01, 1999
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
K991965 · LYL
Purilens, Inc.
Ophthalmic · 113d
Cleared Oct 01, 1999
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
K992271 · LYZ
Shanghai Cosmos Corp.
General Hospital · 86d
Cleared Oct 01, 1999
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992272 · LYZ
Shanghai Cosmos Corp.
General Hospital · 86d
Cleared Oct 01, 1999
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K992276 · MNI
Sulzer Spine-Tech
Orthopedic · 86d
Cleared Oct 01, 1999
GLUMA COMFORT BOND + DESENSITIZER
K992292 · KLE
Heraeus Kulzer, Inc.
Dental · 86d
Cleared Oct 01, 1999
AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION
K992317 · KPS
Adac Laboratories
Radiology · 84d
Cleared Oct 01, 1999
BECTON DICKINSON SYRINGE
K992734 · MEG
Bd Becton Dickinson Vacutainer...
General Hospital · 49d
Cleared Oct 01, 1999
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...
K992775 · KGI
Hologic, Inc.
Radiology · 44d
Cleared Oct 01, 1999
ADVANTA GRAFT (<6MM)
K992958 · DYF
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Oct 01, 1999
ADVANTA GRAFT (>6MM)
K992960 · DSY
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Oct 01, 1999
SILHOUETTE FC
K993090 · KPR
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Sep 30, 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
K990992 · LCP
Roche Diagnostics Corp.
Chemistry · 190d
Cleared Sep 29, 1999
DENZIR
K984201 · EIH
Dentronic AB
Dental · 309d