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
81121–81144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 2000
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
K001759 · JDI
Implex Corp.
Orthopedic · 76d
Cleared Aug 24, 2000
ANTERIOR CERVICAL PLATE SYSTEM
K001847 · KWQ
Encore Orthopedics, Inc.
Orthopedic · 66d
Cleared Aug 24, 2000
HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
K002021 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 52d
Cleared Aug 24, 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K002206 · DQX
Guidant Corp.
Cardiovascular · 34d
Cleared Aug 24, 2000
SUPER 1
K002298 · EJH
Dental Alloy Products, Inc.
Dental · 27d
Cleared Aug 24, 2000
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
K002324 · JDI
Sulzermedica
Orthopedic · 24d
Cleared Aug 24, 2000
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
K002435 · GAW
Axya Medical, Inc.
General & Plastic Surgery · 15d
Cleared Aug 23, 2000
3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
K000355 · JOJ
Minnesota Mining and Mfg. Co.
General Hospital · 201d
Cleared Aug 23, 2000
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
K000859 · BSZ
Charles A. Smith
Anesthesiology · 159d
Cleared Aug 23, 2000
DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND...
K001814 · CCK
Datex-Ohmeda
Anesthesiology · 69d
Cleared Aug 23, 2000
CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
K001943 · NAO
Sangui Biotech, Inc.
Chemistry · 58d
Cleared Aug 23, 2000
RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
K002240 · MUJ
Precision Therapy Intl., Inc.
Radiology · 30d
Cleared Aug 23, 2000
PALM PUMP
K002434 · MEA
Sorenson Medical, Inc.
General Hospital · 14d
Cleared Aug 23, 2000
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
K993950 · FLL
Nien Made Electrnics Corp.
General Hospital · 275d
Cleared Aug 22, 2000
BRACHYSEED
K000475 · KXK
Draximage, Inc.
Radiology · 189d
Cleared Aug 22, 2000
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1
K000969 · FLL
Microlife Corp.
General Hospital · 148d
Cleared Aug 22, 2000
BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION
K001598 · LYC
Col-Bar , Ltd.
Dental · 90d
Cleared Aug 22, 2000
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K001740 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 75d
Cleared Aug 22, 2000
IMPROVED ENLIGHT LV
K001881 · DYH
Sybron Dental Specialties, Inc.
Dental · 62d
Cleared Aug 22, 2000
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER,...
K001935 · CDZ
Beckman Coulter, Inc.
Chemistry · 57d
Cleared Aug 22, 2000
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR...
K002065 · LYY
Comfort Rubber Gloves Industries Sdn....
General Hospital · 46d
Cleared Aug 22, 2000
ELECSYS HCG TEST SYSTEM
K002148 · DHA
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Aug 22, 2000
DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3
K002174 · JJY
Casco-Nerl Diagnostics Corporation...
Chemistry · 34d
Cleared Aug 22, 2000
EPIC SPO2 FINGER SENSOR, MODEL E412-20
K002223 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 29d