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
99385–99408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1996
ADHESIVE BANDAGES WITH OTC DRUG
K943314 · KGX
Johnson & Johnson Consumer Products,...
General & Plastic Surgery · 555d
Cleared Jan 17, 1996
OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES
K951517 · MEH
Osteonics Corp.
Orthopedic · 289d
Cleared Jan 17, 1996
EXL-12SP & 12DP LINAC
K952314 · IYE
Mitsubishi Intl. Corp.
Radiology · 245d
Cleared Jan 17, 1996
LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM
K952329 · DWJ
Progressive Dynamics, Inc.
Cardiovascular · 244d
Cleared Jan 17, 1996
COLORSLIDER RUBELLA
K952544 · LQN
Seradyn, Inc.
Microbiology · 229d
Cleared Jan 17, 1996
HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM
K952970 · JDI
Howmedica Corp.
Orthopedic · 204d
Cleared Jan 17, 1996
DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
K953268 · LWJ
Stelkast Company
Orthopedic · 188d
Cleared Jan 17, 1996
SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
K953453 · FAS
Symbiosis Corp.
Gastroenterology & Urology · 182d
Cleared Jan 17, 1996
ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM
K954022 · IYN
Aloka Co., Ltd.
Radiology · 142d
Cleared Jan 17, 1996
SUTURE WASHER
K954148 · HTN
Acu Med, Inc.
Orthopedic · 134d
Cleared Jan 17, 1996
DG PORTABLE SYSTEM
K954157 · OLT
Medelec , Ltd.
Neurology · 134d
Cleared Jan 17, 1996
TRILOGY ACETABULAR COMPONENT 7MM OFFSET
K954698 · LPH
Zimmer, Inc.
Orthopedic · 97d
Cleared Jan 17, 1996
KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY
K954797 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 91d
Cleared Jan 17, 1996
DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT
K954811 · LPH
Depuy, Inc.
Orthopedic · 90d
Cleared Jan 17, 1996
CERALAS G FREQUENCY DOUBLED ND
K954834 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 89d
Cleared Jan 17, 1996
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE...
K954922 · ESD
Rexton, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 17, 1996
MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE
K954940 · FTA
Mdt Biologic Co.
General & Plastic Surgery · 79d
Cleared Jan 17, 1996
ECLIPSE 2100
K955006 · GEX
Cardiogenes
General & Plastic Surgery · 77d
Cleared Jan 17, 1996
ASPACH 65,000 (MODIFICATION)
K955084 · HSZ
The Anspach Effort, Inc.
Orthopedic · 90d
Cleared Jan 17, 1996
THE TULIP MONO POLAR ROTATABLE ALLIGATOR FORCEP
K955501 · GEI
The Tulip Mfg. Co.
General & Plastic Surgery · 47d
Cleared Jan 17, 1996
THE TULIP MONO POLAR ROTATABLE METZ SCISSORS
K955502 · GEI
The Tulip Mfg. Co.
General & Plastic Surgery · 47d
Cleared Jan 17, 1996
HYCURE
K955506 · KGN
The Hymed Group Corp.
General & Plastic Surgery · 47d
Cleared Jan 17, 1996
TECNOL HYDROGEL WOUND DRESSING
K955575 · MGQ
Tecnol Medical Products, Inc.
General & Plastic Surgery · 41d
Cleared Jan 17, 1996
MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE
K955616 · ETD
Misten Medical Corp.
Ear, Nose, Throat · 37d