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
80377–80400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2000
VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM
K003525 · IYN
Medison America, Inc.
Radiology · 7d
Cleared Nov 21, 2000
ROSETTA-LT/ROSETTA-RX
K002089 · DRG
General Devices
Cardiovascular · 133d
Cleared Nov 21, 2000
SINUSCOPE AND BACCESSORIES
K002214 · EOB
Pollux Endoscopy, Inc.
Ear, Nose, Throat · 120d
Cleared Nov 21, 2000
PURESPERM WASH
K002630 · MQL
Nidacon International AB
Obstetrics & Gynecology · 90d
Cleared Nov 21, 2000
SILMAX PECTORAL IMPLANT
K002633 · MIC
Pillar Surgical, Inc.
General & Plastic Surgery · 90d
Cleared Nov 21, 2000
ARAMIS DERMATOLOGICAL LASER
K002649 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 89d
Cleared Nov 21, 2000
O-PERM 30
K002703 · HQD
Optical Polymer Research, Inc.
Ophthalmic · 83d
Cleared Nov 21, 2000
MICROPAQ, MODELS 402 AND 404
K002725 · DRT
Protocol Systems, Inc.
Cardiovascular · 82d
Cleared Nov 21, 2000
K-DEFIB/PACE, MODEL KDP-60A
K002806 · MKJ
Katecho, Inc.
Cardiovascular · 74d
Cleared Nov 21, 2000
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · FIE
Nipro Medical Corp.
Gastroenterology & Urology · 74d
Cleared Nov 21, 2000
MODEL 6600GE-64: TRAMA NECK ARRAY
K002864 · MOS
Midwest Rf, LLC
Radiology · 69d
Cleared Nov 21, 2000
MINITUB MULTI-PURPOSE CASSETTES
K002961 · MQG
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 60d
Cleared Nov 21, 2000
SPECIALTY TINT SOFT CONTACT LENS
K003079 · LPL
Specialty Tint
Ophthalmic · 49d
Cleared Nov 21, 2000
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K003109 · LPN
Allergan, Inc.
Ophthalmic · 48d
Cleared Nov 21, 2000
CLINIFLO INCENTIVE SPIROMETER
K003146 · BWF
Dhd Healthcare Corp.
Anesthesiology · 42d
Cleared Nov 21, 2000
MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
K003298 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 32d
Cleared Nov 21, 2000
RENEW LS-1
K003317 · EBF
Bisco, Inc.
Dental · 28d
Cleared Nov 21, 2000
PINNACLE R/O II OR RADIFOCUS INTRODUCER II
K003424 · DYB
Terumo Medical Corp.
Cardiovascular · 18d
Cleared Nov 21, 2000
MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR
K003444 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 15d
Cleared Nov 20, 2000
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K002199 · CFR
Pointe Scientific, Inc.,
Chemistry · 123d
Cleared Nov 20, 2000
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
K002605 · JDW
Synthes (Usa)
Orthopedic · 90d
Cleared Nov 20, 2000
PURESPERM 40 AND PURESPERM 80
K002623 · MQL
Nidacon International AB
Obstetrics & Gynecology · 89d
Cleared Nov 20, 2000
SILMAX CONTOUR CARVING BLOCK IMPLANT
K002629 · JOF
Pillar Surgical, Inc.
Ear, Nose, Throat · 89d
Cleared Nov 20, 2000
RADIAL HEAD IMPLANT
K002644 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 88d