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
91465–91488 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1997
MAURICE WORLDWIDE SHUNT SYSTEM
K973525 · JXG
Integra Neurocare, LLC
Neurology · 90d
Cleared Dec 16, 1997
N-TERFACE
K973538 · MGP
Winfield Laboratories, Inc.
General & Plastic Surgery · 89d
Cleared Dec 16, 1997
OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP
K973552 · MTZ
Bio-Vascular, Inc.
Ophthalmic · 88d
Cleared Dec 16, 1997
PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH
K973676 · JJX
Sorrento Biochemical, Inc.
Chemistry · 81d
Cleared Dec 16, 1997
ULTRALON POWDER FREE LATEX SURGICAL GLOVE
K973699 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 78d
Cleared Dec 16, 1997
FLEXVIEW CO2 BLOWER WITH MIST
K973803 · FQH
Ethicon Endo-Surgery, Inc.
General Hospital · 71d
Cleared Dec 16, 1997
T-REX BIOPSY FORCEPS
K973818 · DWZ
Boston Scientific Corp
Cardiovascular · 70d
Cleared Dec 16, 1997
CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
K973919 · LBH
Medental Intl.
Dental · 62d
Cleared Dec 16, 1997
HEARTPORT ENDOAORTIC CLAMP CATHETER
K974175 · DWZ
Heartport, Inc.
Cardiovascular · 40d
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