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
90961–90984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1997
BENEFIT B3--- SERIES
K974254 · FNL
M.C. Healthcare Products, Inc.
General Hospital · 33d
Cleared Dec 16, 1997
ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM
K974322 · DOP
Europa Scientific, Ltd.
Toxicology · 29d
Cleared Dec 15, 1997
COURIER ST BALLOON DILATATION CATHETER
K973008 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 124d
Cleared Dec 15, 1997
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
K973507 · FRO
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Dec 15, 1997
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK...
K973662 · LFR
Boehringer Mannheim Corp.
Chemistry · 81d
Cleared Dec 15, 1997
DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH
K973677 · JJX
Sorrento Biochemical, Inc.
Chemistry · 80d
Cleared Dec 15, 1997
ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH
K973678 · JJX
Sorrento Biochemical, Inc.
Chemistry · 80d
Cleared Dec 15, 1997
BECKMAN CALIBRATOR 2 (CAL2)
K973932 · JIX
Beckman Instruments, Inc.
Chemistry · 61d
Cleared Dec 15, 1997
OPUS 2 - CANAL SERIES (ITC)
K974069 · ESD
Bernafon-Maico, Inc.
Ear, Nose, Throat · 48d
Cleared Dec 15, 1997
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
K974152 · ESD
Bernafon-Maico, Inc.
Ear, Nose, Throat · 41d
Cleared Dec 15, 1997
OPUS 2 - FULL CONCHA SERIES - ITE
K974211 · ESD
Bernafon-Maico, Inc.
Ear, Nose, Throat · 35d
Cleared Dec 12, 1997
SPECULITE
K963391 · MPU
Trylon Corp.
Obstetrics & Gynecology · 471d
Cleared Dec 12, 1997
ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY)
K971528 · IYO
Fujinon, Inc.
Radiology · 228d
Cleared Dec 12, 1997
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12,...
K971905 · DEH
Dako Corp.
Immunology · 203d
Cleared Dec 12, 1997
COMPACT OR COMP-X
K972365 · IZL
Eurotec, S.R.L.
Radiology · 170d
Cleared Dec 12, 1997
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS...
K973494 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Dec 12, 1997
ADVANCE MODULAR TIBIAL COMPONENT
K973524 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Dec 12, 1997
SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM
K973653 · LLZ
Areeda Assoc., Ltd.
Radiology · 78d
Cleared Dec 12, 1997
MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT
K973712 · IZL
Minxray, Inc.
Radiology · 74d
Cleared Dec 12, 1997
MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM,...
K973737 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 73d
Cleared Dec 12, 1997
SWIFT DELIVERY PRODUCT #300
K973942 · HDB
Swift Delivery Products
Obstetrics & Gynecology · 77d
Cleared Dec 12, 1997
RETINAL CUBE
K973950 · HKI
Applied Spectral Imaging , Ltd.
Ophthalmic · 57d
Cleared Dec 12, 1997
SMART MOTORIZED VIEWER
K973965 · IXC
Smartlight, Ltd.
Radiology · 56d
Cleared Dec 12, 1997
SHAH PERMAVENT
K974007 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 52d