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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68377–68400 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 2004
KRYO ART CONTROLLED RATE FREEZER
K032086 · MQG
Planer Plc
Obstetrics & Gynecology · 256d
Cleared Mar 19, 2004
CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50
K032863 · GEX
Biolitec, Inc.
General & Plastic Surgery · 189d
Cleared Mar 19, 2004
CERALAS D 810 DIODE LASER SYSTEM, MODEL D15
K032864 · GEX
Biolitec, Inc.
General & Plastic Surgery · 189d
Cleared Mar 19, 2004
POWERPICC CATHETERS, MODELS 3175155, 3175135
K033389 · LJS
C.R. Bard, Inc.
General Hospital · 148d
Cleared Mar 19, 2004
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K033594 · HQD
Contamac, Ltd.
Ophthalmic · 127d
Cleared Mar 19, 2004
SHAPE LOCKING ENDOSCOPIC OVERTUBE
K033954 · FED
Usgi Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 19, 2004
MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
K033998 · DQA
Masimo Corp.
Anesthesiology · 86d
Cleared Mar 19, 2004
TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS
K034024 · EBI
Bisco, Inc.
Dental · 81d
Cleared Mar 19, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K040099 · LON
Becton, Dickinson & CO
Microbiology · 59d
Cleared Mar 19, 2004
PEDIATRIC AORTIC ROOT CANNULA
K040173 · DWF
Medtronic Perfusion Systems
Cardiovascular · 53d
Cleared Mar 19, 2004
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
K040229 · DXN
A&D Engineering, Inc.
Cardiovascular · 46d
Cleared Mar 19, 2004
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
K040359 · JPA
Instrumentation Laboratory CO
Hematology · 35d
Cleared Mar 19, 2004
KERATO ANALYZER (EKA)
K040373 · NQE
Konan Medical, Inc.
Ophthalmic · 31d
Cleared Mar 19, 2004
MODIFICATION TO VERTE-STACK
K040422 · MQP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Mar 19, 2004
AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
K040547 · DYH
Harry J. Bosworth Co.
Dental · 17d
Cleared Mar 19, 2004
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
K040548 · DYH
Harry J. Bosworth Co.
Dental · 17d
Cleared Mar 18, 2004
MARK 5 NUVO (M5C5)
K032509 · CAW
Nidek Medical Products, Inc.
Anesthesiology · 217d
Cleared Mar 18, 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
K032850 · NBT
Immco Diagnostics, Inc.
Immunology · 188d
Cleared Mar 18, 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
K032860 · NBT
Immco Diagnostics, Inc.
Immunology · 188d
Cleared Mar 18, 2004
ARIOL
K033200 · NQN
Applied Imaging Corp.
Pathology · 168d
Cleared Mar 18, 2004
IVY DEVICES INC. IV/MEDICAL LINE STABILIZER
K033208 · FPA
Ivy Devices, Inc.
General Hospital · 168d
Cleared Mar 18, 2004
ZAP HCG TEST, MODEL 8001
K033297 · JHI
Zbx Corporation
Chemistry · 156d
Cleared Mar 18, 2004
IDI-MRSA
K033415 · NQX
Infectio Diagnostic (I.D.I.), Inc.
Microbiology · 143d
Cleared Mar 18, 2004
INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905
K040036 · MEG
Inviro Medical
General Hospital · 69d