FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
100225–100248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 1996
STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
K950990 · DTQ
Stoeckert Instrumente
Cardiovascular · 322d
Cleared Jan 19, 1996
TRANSQ ELECTRODE PHORESOR II
K954126 · KTB
Iomed, Inc.
Physical Medicine · 140d
Cleared Jan 19, 1996
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525 · BXN
Sherwood Medical Co.
Anesthesiology · 112d
Cleared Jan 19, 1996
THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE &...
K954661 · JOH
Zipper Medical, Inc.
Anesthesiology · 101d
Cleared Jan 19, 1996
MEDCARE YANKAUER SUCTION DEVICE
K954869 · GCX
Medcare Custom Packaging, Inc.
General Hospital · 87d
Cleared Jan 18, 1996
PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM
K950272 · JDR
Ethicon, Inc.
Orthopedic · 360d
Cleared Jan 18, 1996
TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE
K952190 · KPS
Sopha Medical Systems, Inc.
Radiology · 254d
Cleared Jan 18, 1996
ABBOTT XL3M INFUSION PUMP
K952799 · FRN
Abbott Laboratories
General Hospital · 213d
Cleared Jan 18, 1996
DARWIN KNEE SYSTEM (TC3)
K952830 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 212d
Cleared Jan 18, 1996
SCANMASTER DX
K953117 · LMA
Howtek, Inc.
Radiology · 199d
Cleared Jan 18, 1996
ELMED RF-ALERT
K953271 · GEI
Elmed, Inc.
General & Plastic Surgery · 189d
Cleared Jan 18, 1996
TOKUYAMA SOFT RELINING
K953589 · EBI
Tokuyama America, Inc.
Dental · 170d
Cleared Jan 18, 1996
LUMAX(MODIFICATION)
K953734 · FEN
Medamicus, Inc.
Gastroenterology & Urology · 185d
Cleared Jan 18, 1996
HOSPITEC MEDI-BUTLER
K954500 · FMI
Hospitec, Inc.
General Hospital · 112d
Cleared Jan 18, 1996
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE
K954604 · MCW
Heart Technology Mfg., Inc.
Cardiovascular · 106d
Cleared Jan 18, 1996
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
K954646 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 100d
Cleared Jan 18, 1996
BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
K954768 · LZO
Biologically Oriented Prostheses
Orthopedic · 93d
Cleared Jan 18, 1996
SCALEX 800
K954820 · ELC
Dentamerica
Dental · 90d
Cleared Jan 18, 1996
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS
K955051 · OCZ
Olympus America, Inc.
Gastroenterology & Urology · 73d
Cleared Jan 18, 1996
SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
K955119 · HIH
Symbiosis Corp.
Obstetrics & Gynecology · 70d
Cleared Jan 18, 1996
WRIGHT MEDICAL TECHNOLOGY SAWBLADES
K955229 · GFA
Wrightmedicaltechnologyinc
General & Plastic Surgery · 65d
Cleared Jan 18, 1996
PCA +15MM MODULAR FEMORAL HEAD
K955305 · MEH
Howmedica Corp.
Orthopedic · 59d
Cleared Jan 18, 1996
DUKAL TRANSPARENT WOUND DRESSING
K955476 · MGP
Dukal Corp.
General & Plastic Surgery · 49d
Cleared Jan 18, 1996
MICROAIRE SMARTDRIVE SYSTEM
K955591 · HWE
Microaire Surgical Instruments, Inc.
Orthopedic · 42d