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
77737–77760 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 2001
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016 · LZA
Tillotson Healthcare Corp.
General Hospital · 42d
Cleared Oct 19, 2001
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6...
K013135 · DHB
Diagnostic Products Corp.
Immunology · 30d
Cleared Oct 19, 2001
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
MARK II/MARK III MANOMETRIC PERFUSION PUMP
K013154 · FFX
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K013156 · MSX
Data Critical Corp.
Cardiovascular · 28d
Cleared Oct 19, 2001
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH...
K013162 · KNT
Medcomp
Gastroenterology & Urology · 28d
Cleared Oct 19, 2001
ASTRALIS 10, MODELS # 559588, 561859
K013275 · EBZ
Ivoclar Vivadent, Inc.
Dental · 18d
Cleared Oct 19, 2001
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K013356 · FCG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 9d
Cleared Oct 18, 2001
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
K002132 · MUJ
Intelligent Instruments Pvt. , Ltd.
Radiology · 461d
Cleared Oct 18, 2001
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
K003857 · JOW
Sterilmed, Inc.
Cardiovascular · 309d
Cleared Oct 18, 2001
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
K012409 · NHB
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 80d
Cleared Oct 18, 2001
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
K012424 · JAA
Shimadzu Corp.
Radiology · 80d
Cleared Oct 18, 2001
WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
K012522 · ITX
National Therapy Products, Inc.
Radiology · 73d
Cleared Oct 18, 2001
PROSAFE SAFETY SYRINGE
K012726 · MEG
Hou-Se Medical, Inc.
General Hospital · 64d
Cleared Oct 18, 2001
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
K012961 · JDI
Sulzer Orthopedics, Inc.
Orthopedic · 44d
Cleared Oct 18, 2001
N LP(A) CONTROL SY
K013130 · JJX
Dade Behring, Inc.
Chemistry · 29d
Cleared Oct 18, 2001
MR-GUIDE 2000
K013150 · LNH
Ultraguide , Ltd.
Radiology · 28d
Cleared Oct 18, 2001
MOSFET AUTOSENSE, MODEL TN-RD-60
K013279 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 16d
Cleared Oct 17, 2001
SEED SELECTRON MODEL V. 1.0
K010032 · JAQ
Nucletron Corp.
Radiology · 287d
Cleared Oct 17, 2001
HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
K011247 · MQX
Acusupply, Inc.
General Hospital · 177d
Cleared Oct 17, 2001
METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
K012265 · FCW
Circon Video
Gastroenterology & Urology · 90d
Cleared Oct 17, 2001
THEKEN SMALL CEMENT RESTRICTOR
K012278 · JDK
Theken Surgical,Llc
Orthopedic · 90d
Cleared Oct 17, 2001
FLEXI-SITE SP02 EAR SENSOR
K012333 · DPZ
Epic Medical Equipment Services, Inc.
Anesthesiology · 85d