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
78361–78384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2001
MODIFICATION TO XPS 3000 SYSTEM
K011321 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 26, 2001
PARA 5X
K011410 · JPK
Streck Laboratories, Inc.
Hematology · 49d
Cleared Jun 26, 2001
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,...
K011542 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 39d
Cleared Jun 26, 2001
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554 · MIX
Biomet, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
K011579 · JJY
Bio-Rad
Immunology · 35d
Cleared Jun 26, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH...
K011670 · DQA
Datex-Ohmeda
Anesthesiology · 27d
Cleared Jun 25, 2001
SAVINA
K003068 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 266d
Cleared Jun 25, 2001
ORACLE ORAL MASK
K003894 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 189d
Cleared Jun 25, 2001
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · DIO
Teco Diagnostics
Toxicology · 151d
Cleared Jun 25, 2001
WAKO AUTOKIT C4
K010325 · DBI
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
WAKO AUTOKIT C3
K010326 · CZW
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
WAKO LIPID CALIBRATOR
K010334 · JIT
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
INTER-VIAL
K010703 · LHI
Duoject Medical Systems, Inc.
General Hospital · 108d
Cleared Jun 25, 2001
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
K010921 · LDJ
Advantage Diagnostics Corp.
Toxicology · 90d
Cleared Jun 25, 2001
SEP-10S PLUS, AND SP-12S PRO.
K010937 · FRN
Viltechmeda
General Hospital · 88d
Cleared Jun 25, 2001
QUELL DESENSITIZER
K010957 · LBH
Jeneric/Pentron, Inc.
Dental · 87d
Cleared Jun 25, 2001
BRACHYSEED PD-103 MODELS #PD1
K011119 · KXK
Draximage, Inc.
Radiology · 74d
Cleared Jun 25, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · JFJ
Roche Diagnostics Corp.
Chemistry · 91d
Cleared Jun 25, 2001
ICS MEDICAL CHARTR OAE WITH TYMP
K011181 · EWO
Ics Medical Corp.
Ear, Nose, Throat · 68d
Cleared Jun 25, 2001
PORTABELL, MODEL 4200
K011222 · EIA
Bell Dental Products, LLC
Dental · 66d
Cleared Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226 · JIX
Roche Diagnostics Corp.
Chemistry · 66d
Cleared Jun 25, 2001
ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM
K011245 · DZE
Sulzer Dental, Inc.
Dental · 63d
Cleared Jun 25, 2001
PHASE II GBM IGG ANTIBODY EIA TEST
K011348 · MVJ
Scimedx Corp.
Immunology · 54d
Cleared Jun 25, 2001
MICRODOSE CATH, MODELS 90121-201, -202, -203
K011383 · ETD
Durect Corp.
Ear, Nose, Throat · 49d