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
76153–76176 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2002
CODMAN HAKIM SHUNT SYSTEMS
K020667 · JXG
Codman & Shurtleff, Inc.
Neurology · 27d
Cleared Mar 28, 2002
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
K020669 · DTB
Oscor, Inc.
Cardiovascular · 27d
Cleared Mar 28, 2002
HEMOCHRON JR. SIGNATURE +
K020798 · JPA
International Technidyne Corp.
Hematology · 16d
Cleared Mar 27, 2002
MRSA-SCREEN
K011400 · MYI
Denka Seiken'S
Microbiology · 324d
Cleared Mar 27, 2002
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
K012520 · DRF
Cardiac Assist Devices, Inc.
Cardiovascular · 233d
Cleared Mar 27, 2002
GLASS POST
K012849 · ELR
J. Morita USA, Inc.
Dental · 236d
Cleared Mar 27, 2002
WIZAIR DVT
K012994 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 202d
Cleared Mar 27, 2002
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
K013488 · JXG
Sophysa SA
Neurology · 159d
Cleared Mar 27, 2002
OMNI OXYGEN SYSTEM, MODEL 1000
K013931 · CAW
Sequal Technologies, Inc.
Anesthesiology · 119d
Cleared Mar 27, 2002
UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
K013949 · FPA
Churchill Medical Systems, Inc.
General Hospital · 117d
Cleared Mar 27, 2002
TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE
K014260 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 27, 2002
NORAPAD PLAIN
K014268 · HBA
Perlei Medical, Inc.
Neurology · 90d
Cleared Mar 27, 2002
PERIOLASE ND:YAG DENTAL LASER SYSTEM
K014272 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Mar 27, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
K014304 · HWC
Triage Medical, Inc.
Orthopedic · 86d
Cleared Mar 27, 2002
EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006,...
K020031 · GEI
Neothermia Corp.
General & Plastic Surgery · 82d
Cleared Mar 27, 2002
PROCERA ALLCERAM BRIDGE MATERIAL
K020269 · EIH
Procera Sandvik AB
Dental · 58d
Cleared Mar 27, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020322 · LON
Becton, Dickinson & CO
Microbiology · 71d
Cleared Mar 27, 2002
UNIVERSAL BONE PLATE III SYSTEM (UBP III)
K020611 · HRS
Spinal Concepts, Inc.
Orthopedic · 30d
Cleared Mar 27, 2002
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K020680 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 23d
Cleared Mar 27, 2002
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
K020806 · LOJ
Bayer Corp.
Immunology · 15d
Cleared Mar 27, 2002
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
K020881 · FRN
Science Incorporated
General Hospital · 9d
Cleared Mar 26, 2002
M3 (MIRCO-MULTILEAF COLLIMATOR
K004022 · IYE
Brainlab AG
Radiology · 454d
Cleared Mar 26, 2002
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT...
K010131 · KDI
Aksys, Ltd.
Gastroenterology & Urology · 434d
Cleared Mar 26, 2002
FLOWTRON UNIVERSAL, MODEL AC600
K010744 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 378d