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
72529–72552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2003
POWDERED VINYL EXAMINATION GLOVES
K024016 · LYZ
Top Glove (Zhangjiagang) Co. , Ltd.
General Hospital · 61d
Cleared Feb 03, 2003
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
K024118 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 49d
Cleared Feb 03, 2003
EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE
K024355 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 35d
Cleared Feb 03, 2003
ARTHROCARE ENT COBLATOR SURGERY SYSTEM
K030108 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Feb 03, 2003
THERMACOOL TC SYSTEM
K030142 · GEI
Thermage, Inc.
General & Plastic Surgery · 19d
Cleared Jan 31, 2003
RADIOMED MARKER
K022326 · JAK
Radiomed Corporation
Radiology · 197d
Cleared Jan 31, 2003
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
K022596 · DQK
Clover Hi-Tech, Inc.
Cardiovascular · 179d
Cleared Jan 31, 2003
RTDOSEPLAN
K022961 · MUJ
Math Resolutions, LLC
Radiology · 147d
Cleared Jan 31, 2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561 · GKR
International Technidyne Corp.
Hematology · 100d
Cleared Jan 31, 2003
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
K023712 · DKZ
Advantage Diagnostics Corp.
Toxicology · 88d
Cleared Jan 31, 2003
CALIBRATION PACK, MODELS A9100-101S AND A9100-103S
K023792 · JIX
Thermo Orion
Chemistry · 79d
Cleared Jan 31, 2003
AHL GENERIC GLASS IONOMER LUTING CEMENT
K023981 · EMA
Advanced Healthcare , Ltd.
Dental · 60d
Cleared Jan 31, 2003
MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160...
K023984 · EOQ
The Olympus Optical Co.
Ear, Nose, Throat · 60d
Cleared Jan 31, 2003
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
K024053 · DTB
Oscor, Inc.
Cardiovascular · 53d
Cleared Jan 31, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML
K024152 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Jan 31, 2003
MODIFICATION TO PENTRA 60 AND PENTRA 60C+
K030144 · GKZ
Abx Diagnostics
Hematology · 16d
Cleared Jan 31, 2003
SETPOINT CHEMISTRY CALIBRATOR
K030169 · JIX
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 30, 2003
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K021340 · DRN
External Counterpulsation Lab
Cardiovascular · 279d
Cleared Jan 30, 2003
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
K022221 · MPB
Deltec, Inc.
Gastroenterology & Urology · 205d
Cleared Jan 30, 2003
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
K023688 · GAF
LeMaitre Vascular, Inc.
General & Plastic Surgery · 90d
Cleared Jan 30, 2003
ANGIONEW-IV
K023701 · DRN
Living Data Technologies Corporation
Cardiovascular · 87d
Cleared Jan 30, 2003
BI-OSTETIC
K023703 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 87d
Cleared Jan 30, 2003
KSEA SCB ACC CONTROL
K023704 · FTA
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 87d
Cleared Jan 30, 2003
GRADIA DIRECT
K023814 · EBF
GC America, Inc.
Dental · 76d