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
81577–81600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 2000
POWDERED PATIENT EXAMINATION GLOVES, LATEX
K001715 · LYY
Fitco Dipped Products Pvt., Ltd.
General Hospital · 30d
Cleared Jul 05, 2000
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)
K001758 · JJY
Medical Analysis Systems, Inc.
Chemistry · 26d
Cleared Jul 05, 2000
BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A
K001770 · DQA
Bci, Inc.
Anesthesiology · 23d
Cleared Jul 05, 2000
MALLINCKRODT, GOODKNIGHT 418S
K001845 · BZD
Mallinckrodt Developpement France
Anesthesiology · 16d
Cleared Jul 05, 2000
TISSOMAT AND SPRAY SET
K981089 · FMF
Baxter Healthcare Corp
General Hospital · 833d
Cleared Jul 05, 2000
IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
K983667 · MQP
Ionics Medical Corp.
Orthopedic · 625d
Cleared Jul 05, 2000
INSTANT-VIEW MORPHINE URINE CASSETTE TEST
K994404 · DPK
Alfa Scientific Designs, Inc.
Toxicology · 190d
Cleared Jul 03, 2000
BIOSCANNER TRIGLYCERIDES TEST STRIPS
K000586 · JGY
Polymer Technology Systems, Inc.
Chemistry · 132d
Cleared Jul 03, 2000
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
K001135 · DYB
Cordis Corp.
Cardiovascular · 84d
Cleared Jul 03, 2000
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING...
K001235 · MRC
Alcon Universal, Ltd.
Ophthalmic · 77d
Cleared Jul 03, 2000
OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
K001848 · DXN
Omron Healthcare, Inc.
Cardiovascular · 14d
Cleared Jul 03, 2000
EZ LDL CHOLESTEROL TEST SYSTEM
K993741 · MRR
Sigma Diagnostics, Inc.
Chemistry · 242d
Cleared Jun 30, 2000
FUTURA SAFETY SYRINGE
K000860 · MEG
Sheila W. Pickering
General Hospital · 105d
Cleared Jun 30, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE...
K000952 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 98d
Cleared Jun 30, 2000
NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
K001059 · KPO
Novex Pharma
Gastroenterology & Urology · 88d
Cleared Jun 30, 2000
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
K001069 · OLW
Physiometrix, Inc.
Neurology · 88d
Cleared Jun 30, 2000
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501
K001081 · DSB
Cardiodynamics International Corp.
Cardiovascular · 87d
Cleared Jun 30, 2000
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED,...
K001095 · CCL
Teledyne Analytical Instruments
Anesthesiology · 87d
Cleared Jun 30, 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
K001101 · GWF
Excel Tech. , Ltd.
Neurology · 86d
Cleared Jun 30, 2000
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
K001103 · GWQ
Excel Tech. , Ltd.
Neurology · 86d
Cleared Jun 30, 2000
GENYX FLEXIBLE INJECTION NEEEDLE
K001146 · FBK
Geny Medical, Inc.
Gastroenterology & Urology · 81d
Cleared Jun 30, 2000
PERFORMER 30 HPS
K001322 · GEX
Cornelia Damsky, Inc.
General & Plastic Surgery · 65d
Cleared Jun 30, 2000
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
K001611 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 36d
Cleared Jun 30, 2000
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT...
K001664 · MHX
Agilent Technologies, Inc.
Cardiovascular · 30d