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
72073–72096 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2003
SR-130
K030494 · IZL
Source-Ray, Inc.
Radiology · 90d
Cleared May 20, 2003
FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES,...
K030497 · KPO
Fresenius Medical Care
Gastroenterology & Urology · 90d
Cleared May 20, 2003
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
K030502 · MSD
Medcomp
Gastroenterology & Urology · 90d
Cleared May 20, 2003
T.E.A.R. TECH3 MODEL #44TT03
K030507 · IPF
Vision Quest Industries, Inc.
Physical Medicine · 90d
Cleared May 20, 2003
DEPILASE TRIO LASE LASER SYSTEM
K030508 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 90d
Cleared May 20, 2003
AMERITEK SURE-POINT TRACKER SYSTEM
K030518 · ITX
Amertek Medical, Inc.
Radiology · 90d
Cleared May 20, 2003
LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS
K030527 · GEX
Lumenis
General & Plastic Surgery · 90d
Cleared May 20, 2003
CALLOS
K030554 · MQV
Skeletal Kinetics, LLC
Orthopedic · 88d
Cleared May 20, 2003
EVERSTICK POST
K030820 · ELR
Stick Tech , Ltd.
Dental · 67d
Cleared May 20, 2003
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM...
K031053 · EGJ
Selectivemed Components, Inc.
Physical Medicine · 48d
Cleared May 20, 2003
DISPOSABLE POWDERED VINYL EXAM GLOVES
K031134 · LYZ
Elite International, Inc.
General Hospital · 41d
Cleared May 20, 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-120
K031272 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 28d
Cleared May 20, 2003
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398 · DTL
Guidant Corp.
Cardiovascular · 15d
Cleared May 20, 2003
ROSS EMBRACE ENTERAL PUMP
K031407 · LZH
Ross Product Div. Abbott Laboratories
General Hospital · 15d
Cleared May 19, 2003
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
K030631 · FTL
Prosurg, Inc.
General & Plastic Surgery · 80d
Cleared May 19, 2003
DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC,...
K030952 · DQA
Dolphin Medical, Inc.
Anesthesiology · 54d
Cleared May 19, 2003
HEMOSIL FACTOR X DEFICIENT PLASMA
K031122 · GJT
Instrumentation Laboratory CO
Hematology · 41d
Cleared May 19, 2003
MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
K031285 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 26d
Cleared May 16, 2003
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
K023857 · NOM
Bio-Rad
Microbiology · 177d
Cleared May 16, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K023908 · JDK
Interpore Cross Intl.
Orthopedic · 172d
Cleared May 16, 2003
PEAK MOTUS
K030714 · LXJ
Peak Performance Technologies, Inc.
Physical Medicine · 71d
Cleared May 16, 2003
CD HORIZON SPINAL SYSTEM
K030932 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 52d
Cleared May 16, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML
K030986 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared May 16, 2003
EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO &...
K031078 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 42d