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
83185–83208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2000
CAMLOG SCREW IMPLANT SYSTEM
K000099 · DZE
Altatec Biotechnologies
Dental · 15d
Cleared Jan 28, 2000
CAMLOG ROOTFORM IMPLANT SYSTEM
K000100 · DZE
Altatec Biotechnologies
Dental · 15d
Cleared Jan 28, 2000
MAGNA ABUTMENT
K984297 · DZE
Factor, Ii, Inc.
Dental · 423d
Cleared Jan 28, 2000
ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
K990340 · MAI
Arthrex, Inc.
Orthopedic · 359d
Cleared Jan 28, 2000
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K991162 · LZO
Smith & Nephew, Inc.
Orthopedic · 296d
Cleared Jan 28, 2000
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR...
K992273 · MHX
Hewlett-Packard GmbH
Cardiovascular · 205d
Cleared Jan 28, 2000
HENRY SCHEIN SURGICAL MASK
K992604 · FXX
Mitsui Textile Corp.
General Hospital · 178d
Cleared Jan 28, 2000
ADVANCED D-DIMER
K992957 · DAP
Dade Behring, Inc.
Hematology · 148d
Cleared Jan 28, 2000
NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON...
K993595 · DZE
Nobel Biocare Uas, Inc.
Dental · 95d
Cleared Jan 28, 2000
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
K993667 · DSY
Sulzermedica
Cardiovascular · 88d
Cleared Jan 28, 2000
RIM-FIX, ACETABULAR CUP
K993713 · JDI
Surgical Implants, Inc.
Orthopedic · 86d
Cleared Jan 28, 2000
COAGULATION ELECTRODE, MODEL 2000
K993900 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 73d
Cleared Jan 28, 2000
BLUE NITRILE EXAMINATION GLOVES - POWDER FREE
K994064 · LZA
Glove Source, Inc.
General Hospital · 58d
Cleared Jan 28, 2000
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
K994082 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 56d
Cleared Jan 28, 2000
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
K994085 · DHA
Diagnostic Products Corp.
Chemistry · 56d
Cleared Jan 28, 2000
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115 · JMO
Dade Behring, Inc.
Chemistry · 53d
Cleared Jan 28, 2000
IMPREGUM PENTA M MONOSOFT
K994192 · ELW
Espe Dental AG
Dental · 46d
Cleared Jan 28, 2000
IMPREGUM PENTA DUOSOFT
K994193 · ELW
Espe Dental AG
Dental · 46d
Cleared Jan 28, 2000
SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES...
K994248 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 43d
Cleared Jan 27, 2000
GAMBRO DQM 200
K990039 · LFP
Gambro Healthcare
Chemistry · 386d
Cleared Jan 27, 2000
STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM...
K991023 · FRG
Case Medical, Inc.
General Hospital · 304d
Cleared Jan 27, 2000
METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
K991355 · CAF
Instrumentation Industries, Inc.
Anesthesiology · 283d
Cleared Jan 27, 2000
EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM
K991935 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 232d
Cleared Jan 27, 2000
ELECTROSURGICAL ELECTRODE FAMILY
K992045 · GEI
Genesis Medical, Inc.
General & Plastic Surgery · 224d