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
86377–86400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1999
SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)
K983194 · MED
Sporicidin Intl.
General Hospital · 175d
Cleared Mar 05, 1999
ACCU GUIDE
K984382 · IYO
Tayman Medical, Inc.
Radiology · 87d
Cleared Mar 05, 1999
AURA DYE LASER SYSTEM (ADLS)
K984424 · GEX
Laserscope
General & Plastic Surgery · 84d
Cleared Mar 05, 1999
ORBSCAN
K984443 · MXK
Technolas Perfect Vision GmbH
Ophthalmic · 81d
Cleared Mar 05, 1999
COOL-TIP RF SYSTEM
K984552 · GEI
Radionics, Inc.
General & Plastic Surgery · 73d
Cleared Mar 05, 1999
SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM
K984602 · HSB
Syntec Scientific Corp.
Orthopedic · 67d
Cleared Mar 05, 1999
PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC...
K984607 · FBP
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 67d
Cleared Mar 05, 1999
MAXIM REMOVABLE MOLDED POLY TIBIA
K984623 · JWH
Biomet, Inc.
Orthopedic · 65d
Cleared Mar 05, 1999
MULTITAK SS BUTTONS
K990156 · MBI
Bonutti Research
Orthopedic · 45d
Cleared Mar 05, 1999
BONE ANCHOR SYSTEM III (BAS III)
K990295 · MBI
Boston Scientific Corp
Orthopedic · 35d
Cleared Mar 05, 1999
EXMOOR SUCTION CLEARANCE KIT
K990366 · LRC
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 28d
Cleared Mar 04, 1999
EBV-VCA IGG ELISA TEST SYSTEM
K981812 · LSE
Diamedix Corp.
Microbiology · 286d
Cleared Mar 04, 1999
LIGHTSHEER LONG PULSE RUBY LASER
K982980 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 190d
Cleared Mar 04, 1999
POLYMER OBL SB ANCHOR / SUTURE COMBINATION
K982996 · JDR
Orthopaedic Biosystems, Ltd.
Orthopedic · 189d
Cleared Mar 04, 1999
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K983071 · MQM
Respironics, Inc.
Chemistry · 183d
Cleared Mar 04, 1999
NATURAL BRAND ACUPUNCTURE NEEDLES
K983671 · MQX
Tcm Supply Corp.
General Hospital · 136d
Cleared Mar 04, 1999
ALLISON MEDICAL INSULIN SYRINGE (AMIS)
K984017 · FMF
Allison Medical, Inc.
General Hospital · 112d
Cleared Mar 04, 1999
AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR
K984352 · GEI
Aaron Medical Industries
General & Plastic Surgery · 90d
Cleared Mar 04, 1999
TRANSFX EXTERNAL FIXATION SYSTEM
K984357 · LXT
Immedica, Inc.
Orthopedic · 87d
Cleared Mar 04, 1999
NERVE BLOCK INFUSION KIT
K984502 · MEB
I-Flow Corp.
General Hospital · 76d
Cleared Mar 04, 1999
VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
K984596 · GNR
Zymetx, Inc.
Microbiology · 66d
Cleared Mar 04, 1999
MONOPAQUE
K990315 · EBF
Ivoclar North America, Inc.
Dental · 31d
Cleared Mar 04, 1999
OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII
K990326 · HAW
Radionics Software Applications, Inc.
Neurology · 30d
Cleared Mar 04, 1999
MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES
K990379 · GCJ
Dexide, Inc.
General & Plastic Surgery · 24d