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
104521–104544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1995
SCIPOTEX POWDER FREE EXAM GLOVES (BEADED)
K942511 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 253d
Cleared Feb 03, 1995
SIGMA ELITE
K942545 · CAD
Penlon , Ltd.
Anesthesiology · 248d
Cleared Feb 03, 1995
QUIK COMBO
K943301 · DRX
Physio-Control Corp.
Cardiovascular · 210d
Cleared Feb 03, 1995
PVK-357AT
K943303 · IYO
Toshiba America Medical Systems, In.C
Radiology · 210d
Cleared Feb 03, 1995
CEILING SUSPENDED C-ARM SUPPORT MH-100
K943545 · IZI
Shimadzu Medical Systems
Radiology · 197d
Cleared Feb 03, 1995
ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED)
K943566 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 196d
Cleared Feb 03, 1995
SCIPOTEX
K943868 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 179d
Cleared Feb 03, 1995
SYSMEX K-4500
K943894 · GKZ
Sysmex Corp.
Hematology · 178d
Cleared Feb 03, 1995
VISION SYSTEM COLONSCOPE
K943895 · FDF
Vision-Sciences, Inc.
Gastroenterology & Urology · 178d
Cleared Feb 03, 1995
RADIAS RED CELL FOLATE IMMUNOASAY
K944212 · CGN
Bio-Rad
Chemistry · 158d
Cleared Feb 03, 1995
ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER
K944227 · GKP
Medical Laboratory Automation...
Hematology · 155d
Cleared Feb 03, 1995
LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER
K944344 · BWF
Lung Technologies, Inc.
Anesthesiology · 150d
Cleared Feb 03, 1995
DEXTER ISOKINETIC
K944732 · IKK
Cedaron Medical, Inc.
Physical Medicine · 162d
Cleared Feb 03, 1995
CALIBRATION GAS
K944998 · BXK
Sunox, Inc.
Anesthesiology · 113d
Cleared Feb 03, 1995
MULTIPLE
K945164 · LYY
Protection Gloves Sdn. Bhd.
General Hospital · 105d
Cleared Feb 03, 1995
AIMS CANNULATED ACL SCREW (7MM DIAMETER)
K945236 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 99d
Cleared Feb 03, 1995
PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)
K945461 · DTL
Medtronics Interventional Vascular
Cardiovascular · 88d
Cleared Feb 03, 1995
PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM
K945463 · BSZ
Draeger Medical, Inc.
Anesthesiology · 88d
Cleared Feb 03, 1995
CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352
K945572 · GWG
Johnson & Johnson Professionals, Inc.
Neurology · 81d
Cleared Feb 03, 1995
5F ENVOY(TM) GUIDING CATHETER
K945705 · DQY
Cordis Neurovascular, Inc.
Cardiovascular · 87d
Cleared Feb 03, 1995
PHENYTION EIA TEST
K945725 · DIP
Diagnostic Reagents, Inc.
Toxicology · 73d
Cleared Feb 03, 1995
60 FUNDUS CAMERA CF-60UV
K946058 · HKI
Canon USA, Inc.
Ophthalmic · 87d
Cleared Feb 03, 1995
CHEMSPEX(TM) AMMONIA CONTROL
K946143 · JJX
Clinical Controls, Inc.
Chemistry · 49d
Cleared Feb 03, 1995
HELIODENT MD
K950030 · EAP
Pelton & Crane Co.
Radiology · 30d