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
94321–94344 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1997
EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
K964307 · KGI
Lunar Corp.
Radiology · 169d
Cleared Apr 16, 1997
PICC CATHETER/MIDLINE CATHETER
K964447 · LJS
Menlo Care, Inc.
General Hospital · 161d
Cleared Apr 16, 1997
HR POLYURETHANE PICC AND MIDLINE CATHETERS
K964556 · LJS
Johnson & Johnson Medical, Inc.
General Hospital · 154d
Cleared Apr 16, 1997
N-ASSAY TIA FIBRINOGEN TEST KIT
K965113 · KQJ
Crestat Diagnostics, Inc.
Hematology · 117d
Cleared Apr 16, 1997
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
K970099 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 93d
Cleared Apr 16, 1997
MODEL 1700 TRANQUILITY BILEVEL SYSTEM
K970173 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 90d
Cleared Apr 16, 1997
PIXI BONE DENSITOMETER
K970224 · KGI
Lunar Corp.
Radiology · 85d
Cleared Apr 16, 1997
EDTA CAVIT
K970246 · EBF
Karolinski
Dental · 85d
Cleared Apr 16, 1997
INNOVASIVE 8MM LIGAMENT FASTENER
K970316 · MBI
Innovasive Devices, Inc.
Orthopedic · 82d
Cleared Apr 16, 1997
CBC-4K HEMATOLOGY CONTROL
K970331 · JPK
R&D Systems, Inc.
Hematology · 78d
Cleared Apr 16, 1997
PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
K970439 · MKY
Progressive Surgical Products, Inc.
General & Plastic Surgery · 70d
Cleared Apr 16, 1997
FOUNDATION INDIRECT COMPOSITE RESIN
K970495 · EBF
Sybron Dental Specialties, Inc.
Dental · 65d
Cleared Apr 16, 1997
STATNET
K970525 · IZI
Gorca Systems, Inc.
Radiology · 64d
Cleared Apr 16, 1997
700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES
K970719 · MKJ
Cardiotronics Systems, Inc.
Cardiovascular · 48d
Cleared Apr 16, 1997
HEIDELBERG EXTERNAL FIXATOR
K970751 · JDW
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 44d
Cleared Apr 16, 1997
PRECISE
K970827 · EJH
Allan Schulman,D.D.S., M.S.
Dental · 41d
Cleared Apr 16, 1997
HANAULUX BLUE 80 HOSPITAL
K970886 · FSS
Heraeus Med GmbH
General & Plastic Surgery · 69d
Cleared Apr 16, 1997
SLIPPERY GLASS
K970941 · EIH
Jeneric/Pentron, Inc.
Dental · 34d
Cleared Apr 16, 1997
CABLE HOLDER, SUCTION TUBE HOLDER
K971040 · GEI
Contour Fabricators, Inc.
General & Plastic Surgery · 26d
Cleared Apr 15, 1997
EGS4000
K955666 · IPF
S&P Electrical Industries, Inc.
Physical Medicine · 489d
Cleared Apr 15, 1997
CONTINUOUS FLUSH DEVICE
K962129 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 316d
Cleared Apr 15, 1997
HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT...
K964382 · CAH
Gibeck, Inc.
General Hospital · 162d
Cleared Apr 15, 1997
EXL-12SP,12DP,15DP,20DP LINAC
K970137 · IYE
Mitsubishi Electronics America, Inc.
Radiology · 90d
Cleared Apr 15, 1997
ROLL AID
K970164 · ITI
Stand Aid of Iowa, Inc.
Physical Medicine · 89d