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
88369–88392 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1998
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS...
K983053 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 50d
Cleared Oct 21, 1998
CERALAS D LASER SYSTEM, MODEL # CERALAS D15
K983058 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 50d
Cleared Oct 21, 1998
BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR
K983186 · MAI
Linvatec Corp.
Orthopedic · 40d
Cleared Oct 21, 1998
XPS DRILL SYSTEM
K983224 · ERL
Xomed, Inc.
Ear, Nose, Throat · 37d
Cleared Oct 21, 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
K983258 · MNI
Spinal Concepts, Inc.
Orthopedic · 35d
Cleared Oct 21, 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM
K983260 · MNI
Spinal Concepts, Inc.
Orthopedic · 35d
Cleared Oct 21, 1998
ULTRACISION 5MM INSTRUMENTS
K983316 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 30d
Cleared Oct 21, 1998
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
K983416 · JGJ
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Oct 20, 1998
DX-480, ADD ON DIGITAL IMAGER
K981880 · KPR
Wuestec Medical, Inc.
Radiology · 145d
Cleared Oct 20, 1998
UNIGRAFE
K982699 · LYC
Unicare Biomedical
Dental · 78d
Cleared Oct 20, 1998
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888 · LJT
Boston Scientific Corp
General Hospital · 64d
Cleared Oct 20, 1998
ROEKO SEAL
K983037 · KIF
Roeko Ulm, Roescheisen GmbH & Co.
Dental · 50d
Cleared Oct 19, 1998
LEISEGANG VIDEO COLPOSCOPE
K981958 · HEX
Netoptix Corp.
Obstetrics & Gynecology · 137d
Cleared Oct 19, 1998
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
K982299 · DQO
Daig Corp.
Cardiovascular · 110d
Cleared Oct 19, 1998
BMP CABLE SYSTEM
K982545 · JDQ
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 19, 1998
MLT 30 LASER
K982548 · GEX
Medical Laser Technologies , Ltd.
General & Plastic Surgery · 90d
Cleared Oct 19, 1998
SECURALLOY
K982671 · EJJ
Specialites Septodont
Dental · 80d
Cleared Oct 19, 1998
GC RELINE
K982695 · EBI
GC America, Inc.
Dental · 77d
Cleared Oct 19, 1998
ZINFOS ZINC PHOSPHATE CEMENT
K982913 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 61d
Cleared Oct 19, 1998
DISETRONIC PEN
K982966 · FMF
Disetronic Medical Systems
General Hospital · 55d
Cleared Oct 19, 1998
PERITRON PERINEOMETER MODEL 9300V OR 9300A
K983052 · HIR
Cardio Design Pty. , Ltd.
Gastroenterology & Urology · 48d
Cleared Oct 19, 1998
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
K983381 · HEB
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 24d
Cleared Oct 19, 1998
SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER,...
K983406 · FLL
Banta Healthcare Group, Ltd.
General Hospital · 21d
Cleared Oct 16, 1998
UROSURGE UROTHERM FLUID WARMING SYSTEM
K965136 · LHC
Princeton Regulatory Assoc.
General Hospital · 662d