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
82081–82104 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 2000
POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K001165 · LYY
Medipure Corporation (M) Sdn. Bhd.
General Hospital · 86d
Cleared Jul 05, 2000
CORRECT PLUS
K001218 · ELW
Jeneric/Pentron, Inc.
Dental · 79d
Cleared Jul 05, 2000
DANIELS SHARPSMART REUSABLE SHARPS CONTAINER
K001337 · MMK
The Daniels Corp.
General Hospital · 69d
Cleared Jul 05, 2000
SUPREMCAST V
K001383 · EJH
American Dent-All, Inc.
Dental · 64d
Cleared Jul 05, 2000
ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
K001418 · EIH
Procera Sandvik, Inc.
Dental · 61d
Cleared Jul 05, 2000
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
K001430 · BTL
Vortran Medical Technology 1, Inc.
Anesthesiology · 61d
Cleared Jul 05, 2000
DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE
K001432 · LYZ
Shanghai PM Plastics Ent. Co., Ltd.
General Hospital · 58d
Cleared Jul 05, 2000
R&D PROJECT DW269#25
K001469 · EJS
Ivoclar North America, Inc.
Dental · 56d
Cleared Jul 05, 2000
GRADIA
K001518 · EBF
GC America, Inc.
Dental · 50d
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