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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68473–68496 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 2004
WBR-FHR, WBR-FWB
K040370 · KPS
Ultraspect , Ltd.
Radiology · 27d
Cleared Mar 11, 2004
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K040453 · DRM
Revivant Corp.
Cardiovascular · 17d
Cleared Mar 11, 2004
MEDIPACS
K040486 · LLZ
Neobit Co., Ltd.
Radiology · 15d
Cleared Mar 11, 2004
VITALAB AMYLASE REAGENT
K040534 · JFJ
Clinical Data, Inc.
Chemistry · 9d
Cleared Mar 10, 2004
S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
K030797 · BZD
ResMed Corp
Anesthesiology · 363d
Cleared Mar 10, 2004
POGS 33
K030920 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 352d
Cleared Mar 10, 2004
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K032803 · BSZ
Datex-Ohmeda
Anesthesiology · 183d
Cleared Mar 10, 2004
VIDAPORT INTRAOSSEOUS INFUSION SYSTEM
K032885 · FMI
Vidacare Corporation
General Hospital · 176d
Cleared Mar 10, 2004
DIRECT HDL-CHOLESTEROL LIQUID COLOR
K032932 · LBS
Stanbio Laboratory
Chemistry · 170d
Cleared Mar 10, 2004
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
K033080 · CAZ
Portex, Inc.
Anesthesiology · 163d
Cleared Mar 10, 2004
LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
K033518 · BZG
Custom Plastic Products
Anesthesiology · 124d
Cleared Mar 10, 2004
STARLUX PULSED LIGHT SYSTEM
K033549 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 119d
Cleared Mar 10, 2004
RESMED S8 PRIME CPAP SYSTEM
K033841 · BZD
Resmed, Ltd.
Anesthesiology · 91d
Cleared Mar 10, 2004
ELECTRO-LUBE
K033880 · GEI
Mectra Labs, Inc.
General & Plastic Surgery · 86d
Cleared Mar 10, 2004
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
K033921 · JIF
Diagnostic Chemicals , Ltd.
Chemistry · 83d
Cleared Mar 10, 2004
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
K034000 · CDT
Clinical Data, Inc.
Chemistry · 77d
Cleared Mar 10, 2004
RNK TELEPHONIC STETHOSCOPE, MODEL TR-1
K034046 · DQD
Rnk Products
Cardiovascular · 72d
Cleared Mar 10, 2004
R&D GLU-LINE HEMATOLOGY CONTROL
K034048 · JJX
R&D Systems, Inc.
Chemistry · 71d
Cleared Mar 10, 2004
HEALTH BUDDY WITH BUDDYLINK
K040086 · DXN
Health Hero Network, Inc.
Cardiovascular · 54d
Cleared Mar 10, 2004
LIQUICHEK CARDIAC MARKER CONTROL LT
K040277 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 34d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
K040431 · DAO
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
K040434 · DEW
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435 · CZP
Roche Diagnostics Corp.
Immunology · 20d
Cleared Mar 10, 2004
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296
K040471 · JIT
Olympus America, Inc.
Chemistry · 15d