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
89641–89664 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1998
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K980983 · JEY
Biomedics
Dental · 84d
Cleared Jun 09, 1998
QUITETIP
K981109 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 74d
Cleared Jun 09, 1998
ETEST BENZYLPENICILLIN
K981135 · JWY
Ab Biodisk
Microbiology · 71d
Cleared Jun 09, 1998
ETEST FOSFOMYCIN
K981136 · JWY
Ab Biodisk
Microbiology · 71d
Cleared Jun 09, 1998
ETEST CEFOTAXIME
K981137 · JWY
Ab Biodisk
Microbiology · 71d
Cleared Jun 09, 1998
CLEAR (TM) LICE EGG REMOVER SYSTEM
K981147 · LJL
Care Technologies, Inc.
General Hospital · 71d
Cleared Jun 09, 1998
CEFDINIR, 5 UG, SENSI-DISC
K981517 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 42d
Cleared Jun 09, 1998
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
K981743 · CKB
Olympus America, Inc.
Chemistry · 22d
Cleared Jun 08, 1998
NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
K974292 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 206d
Cleared Jun 08, 1998
FUTURELASE 3000/3002 ERBIUM LASER SYSTEM
K974641 · GEX
Buckman Co., Inc.
General & Plastic Surgery · 175d
Cleared Jun 08, 1998
PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM
K974880 · IYO
Perception, Inc.
Radiology · 160d
Cleared Jun 08, 1998
MUCHECK MONITOR UNIT VALIDATION PROGRAM
K980904 · IYE
Medical Dosimetry Services, Inc.
Radiology · 90d
Cleared Jun 08, 1998
MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
K980946 · FFX
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 87d
Cleared Jun 08, 1998
IIRAD DIRECTRAY OPERATOR CONSOLE
K980970 · LLZ
Sterling Diagnostic Imaging, Inc.
Radiology · 84d
Cleared Jun 08, 1998
E.CAM LSO 311 PET/SPECT SYSTEM
K981027 · KPS
Cti Pet Systems, Inc.
Radiology · 81d
Cleared Jun 08, 1998
AMY
K981216 · JFJ
Abbott Laboratories
Chemistry · 66d
Cleared Jun 08, 1998
OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND...
K981543 · EOQ
The Olympus Optical Co.
Ear, Nose, Throat · 39d
Cleared Jun 08, 1998
IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM
K981560 · JWH
Implex Corp.
Orthopedic · 38d
Cleared Jun 08, 1998
IRON
K981581 · CFM
Abbott Laboratories
Chemistry · 35d
Cleared Jun 08, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K981622 · JJX
Dade Behring, Inc.
Chemistry · 32d
Cleared Jun 08, 1998
CO2
K981840 · KHS
Abbott Laboratories
Chemistry · 13d
Cleared Jun 05, 1998
PERACIDIN DIALYZER REPROCESSING CONCENTRATE
K962959 · MED
Hdc Medical, Inc.
General Hospital · 675d
Cleared Jun 05, 1998
FLUTTER D
K972859 · BYI
Bradstreet Clinical Research Assoc.,...
Anesthesiology · 305d
Cleared Jun 05, 1998
PROVI CEMENT
K973201 · EMA
S & C Polymer GmbH
Dental · 283d