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
80881–80904 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2000
IM-6 MICROINJECTOR
K003304 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
C. DIFFICILE TOX A/B II
K003306 · LLH
Techlab, Inc.
Microbiology · 33d
Cleared Nov 22, 2000
DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE,...
K003307 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 30d
Cleared Nov 22, 2000
DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50...
K003309 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 30d
Cleared Nov 22, 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA,...
K003321 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 29d
Cleared Nov 22, 2000
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K003336 · FGE
Cordis Corp.
Gastroenterology & Urology · 28d
Cleared Nov 22, 2000
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353 · LZA
Medline Industries, Inc.
General Hospital · 27d
Cleared Nov 22, 2000
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
K003365 · FGE
Cordis Corp.
Gastroenterology & Urology · 26d
Cleared Nov 22, 2000
JAMSHIDI MARROW ACQUISITION CRADLE
K003370 · KNW
Allegiance Healthcare Corp.
Gastroenterology & Urology · 23d
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