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
73201–73224 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2003
AVANT GUARDIAN 101
K024018 · KZE
Avant Medical Corporation
General Hospital · 44d
Cleared Jan 17, 2003
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
K024020 · FTC
Theralight, Inc.
General & Plastic Surgery · 43d
Cleared Jan 17, 2003
SURESET 3.0 ML RESERVOIR, MODEL 24-103
K024056 · FRN
Applied Diabetes Research, Incorporated
General Hospital · 39d
Cleared Jan 17, 2003
LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
K024218 · LKJ
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
K024220 · DHN
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
K024232 · LKJ
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
ULTRASOUND SCANNER, TYPE 2400
K024236 · IYN
B & K Medical A/S
Radiology · 25d
Cleared Jan 17, 2003
COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K024366 · FZP
Coalescent Surgical
General & Plastic Surgery · 17d
Cleared Jan 17, 2003
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371...
K030012 · JHX
Beckman Coulter, Inc.
Chemistry · 15d
Cleared Jan 17, 2003
CPC BY SORING GMBH
K030028 · GEI
Soring GmbH Medizintechnik
General & Plastic Surgery · 14d
Cleared Jan 17, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K030067 · MJX
Ortho-Clinical Diagnostics
Microbiology · 10d
Cleared Jan 17, 2003
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER...
K030088 · JJY
Biosite Incorporated
Chemistry · 7d
Cleared Jan 16, 2003
MAYBE?MOM MINI OVULATION MICROSCOPE
K013582 · CEP
Maybe?Mom
Chemistry · 443d
Cleared Jan 16, 2003
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
K022976 · DAP
Dade Behring, Inc.
Hematology · 132d
Cleared Jan 16, 2003
MODIFICATION TO STANDARD HUMAN PLASMA
K023141 · JPA
Dade Behring, Inc.
Hematology · 118d
Cleared Jan 16, 2003
RDH-2000
K023213 · EIA
Anodia Systems
Dental · 112d
Cleared Jan 16, 2003
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356 · DXQ
Card Guard Scientific Survival , Ltd.
Cardiovascular · 101d
Cleared Jan 16, 2003
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS...
K023490 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 92d
Cleared Jan 16, 2003
PRE-POWDERED LATEX SURGEON'S GLOVES
K023515 · KGO
Sanrea Healthcare Private Limited
General Hospital · 87d
Cleared Jan 16, 2003
RADIONICS VARILINK 2
K023519 · IYE
Radionics, A Division of Tyco...
Radiology · 87d
Cleared Jan 16, 2003
GENZYME CONTRAST II HCG URINE/SERUM TEST
K023544 · JHI
Genzyme Corp.
Chemistry · 86d
Cleared Jan 16, 2003
ENCLOSE ANASTOMOSIS ASSIST DEVICE
K023682 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 76d
Cleared Jan 16, 2003
TEMPORARY CEMENT-DC010002
K023727 · EMA
GC America, Inc.
Dental · 71d
Cleared Jan 16, 2003
SKINTACT
K023920 · DRX
Leonhard Lang GmbH
Cardiovascular · 52d