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
87601–87624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1998
STARRYSHINE GAUZE SPONGE
K983450 · EFQ
T.C. Dental Products, Inc.
General & Plastic Surgery · 43d
Cleared Nov 12, 1998
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · JPA
American Bioproducts Co.
Hematology · 43d
Cleared Nov 12, 1998
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
K983517 · JKA
Ram Scientific
Chemistry · 36d
Cleared Nov 12, 1998
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
K983578 · JJX
Bio-Rad
Chemistry · 30d
Cleared Nov 12, 1998
CV PERI-GUARD AND VASCU-GUARD
K983602 · DXZ
Bio-Vascular, Inc.
Cardiovascular · 30d
Cleared Nov 12, 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K983706 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 22d
Cleared Nov 12, 1998
STRATEGY CORONARY WIRE GUIDE
K983771 · DQX
Cook, Inc.
Cardiovascular · 17d
Cleared Nov 10, 1998
DIAPACT CRRT
K973322 · KDI
B.Braun Medical, Inc.
Gastroenterology & Urology · 432d
Cleared Nov 10, 1998
CMS-2000
K982843 · MWJ
Industrial Technology Research Institute
Cardiovascular · 90d
Cleared Nov 10, 1998
MR COMPATIBLE LEVEEN NEEDLE ELECTRODE
K982854 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 89d
Cleared Nov 10, 1998
HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
K982876 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Nov 10, 1998
PERIPHERAL NERVE STIMULATION
K982902 · GZF
Medtronic Vascular
Neurology · 88d
Cleared Nov 10, 1998
DIGITAL ECG HOLTER RECORDER, MODEL DR512
K982975 · MWJ
Datrix
Cardiovascular · 76d
Cleared Nov 10, 1998
ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE
K983033 · DQX
Guidant Corp.
Cardiovascular · 71d
Cleared Nov 10, 1998
RESPIRATORY HUMIDIFIER, MODEL # MR850
K983112 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 67d
Cleared Nov 10, 1998
ALLDRESS, ABSORBENT FILM DRESSING
K983554 · KMF
Molnlycke Health Care, Inc.
General & Plastic Surgery · 28d
Cleared Nov 10, 1998
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
K983603 · HAW
Radionics, Inc.
Neurology · 27d
Cleared Nov 10, 1998
ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER
K983736 · CAF
Brasamerica Medical Equipment, Inc.
Anesthesiology · 19d
Cleared Nov 09, 1998
LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
K980800 · EBF
Cosmedent, Inc.
Dental · 252d
Cleared Nov 09, 1998
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
K981871 · DCK
Diagnostic Systems Laboratories, Inc.
Immunology · 165d
Cleared Nov 09, 1998
BRENEB
K982043 · CAF
Bremed Italia, S.R.L.
Anesthesiology · 152d
Cleared Nov 09, 1998
CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
K982167 · GKZ
Coulter Corp.
Hematology · 143d
Cleared Nov 09, 1998
BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE...
K982840 · IYO
Boston Scientific Corp
Radiology · 89d
Cleared Nov 09, 1998
FIBREKOR POST SYSTEM
K983266 · ELR
Jeneric/Pentron, Inc.
Dental · 53d