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
88681–88704 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1998
BIO-OSS COLLAGEN
K974399 · LYC
Geistlich-Pharma
Dental · 299d
Cleared Sep 16, 1998
ORAL POTENTIAL METER (OPM)
K982105 · LFC
Pertec of Wisconsin, Inc.
Dental · 92d
Cleared Sep 16, 1998
FAST-CATH INTRA-CARDIAC INTRODUCER
K982187 · DYB
Daig Corp.
Cardiovascular · 86d
Cleared Sep 16, 1998
MINI POLYURETHANE CATHETER
K982507 · LJT
Med Institute, Inc.
General Hospital · 58d
Cleared Sep 16, 1998
TBIL
K983133 · CIG
Abbott Laboratories
Chemistry · 8d
Cleared Sep 15, 1998
BIO-OSS ANORGANIC BOVINE BONE
K970321 · LYC
Geistlich-Pharma
Dental · 595d
Cleared Sep 15, 1998
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
K970700 · MSE
Fresenius USA, Inc.
Gastroenterology & Urology · 567d
Cleared Sep 15, 1998
CLEAN SOURCE I, MODEL CS1000
K981144 · EIA
Aquarius Technologies, Inc.
Dental · 169d
Cleared Sep 15, 1998
BIOPAK MEASUREMENT SYSTEM
K981563 · KZM
Bio-Research Associates, Inc.
Dental · 137d
Cleared Sep 15, 1998
UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
K981573 · JFH
United Biotech, Inc.
Chemistry · 134d
Cleared Sep 15, 1998
HEMAPROMPT
K981661 · KHE
Aerscher Diagnostics
Hematology · 132d
Cleared Sep 15, 1998
VARIOUS DENTAL IMPLANTS
K982111 · DZE
Biotech Medical Instruments Corp.
Dental · 91d
Cleared Sep 15, 1998
OSCILLOMATE EMS NIBP MONITOR MODEL 9001
K982135 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 90d
Cleared Sep 15, 1998
BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM
K982139 · JEY
Bionx Implants, Inc.
Dental · 90d
Cleared Sep 15, 1998
SPECTRUM 800 CURING UNIT
K982318 · EBF
Dentsply Intl.
Dental · 75d
Cleared Sep 15, 1998
ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48,...
K982343 · DHB
Pharmacia & Upjohn Co.
Immunology · 71d
Cleared Sep 15, 1998
PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.
K982480 · EIA
Dentalview, Inc.
Dental · 61d
Cleared Sep 15, 1998
HDLC PRECIPITATING REAGENT
K982539 · LBS
Ac Biochemicals, Inc.
Chemistry · 56d
Cleared Sep 15, 1998
RENEW
K982729 · EBF
Bisco, Inc.
Dental · 41d
Cleared Sep 14, 1998
UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
K972382 · CIG
Arrows Co., Ltd.
Chemistry · 445d
Cleared Sep 14, 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
K980566 · FOZ
Boston Scientific Corp
General Hospital · 213d
Cleared Sep 14, 1998
LICHEN, BACTERIAL IN LINE BREATHING FILTER
K980662 · CAH
Dhd Healthcare Corp.
General Hospital · 206d
Cleared Sep 14, 1998
DILKES LASER/SUCTION CANNULAE
K981143 · GEX
Exmoor Plastics , Ltd.
General & Plastic Surgery · 168d
Cleared Sep 14, 1998
AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200...
K981570 · GEI
Aaron Medical Industries
General & Plastic Surgery · 133d