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
100897–100920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1995
AMENDMENTS TO MULTIFOCUS
K951002 · ESD
Oticon A/S
Ear, Nose, Throat · 203d
Cleared Sep 18, 1995
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
K951258 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 181d
Cleared Sep 18, 1995
OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM...
K952634 · DZE
Opti-Max
Dental · 102d
Cleared Sep 18, 1995
BRANEMARK SYSTEM DRILLS AND COUNTERSINKS
K952685 · DZE
Nobelpharma USA, Inc.
Dental · 98d
Cleared Sep 18, 1995
ADVANCED LASER MULTILINE SYSTEM, ALY
K952796 · GEX
Advanced Laser Services Corp.
General & Plastic Surgery · 91d
Cleared Sep 18, 1995
EPICARDIA
K952846 · DQK
Medicomp, Inc.
Cardiovascular · 89d
Cleared Sep 18, 1995
BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM
K952886 · DZE
Nobelpharma USA, Inc.
Dental · 87d
Cleared Sep 18, 1995
OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS
K952888 · LMB
Olympus America, Inc.
Radiology · 87d
Cleared Sep 18, 1995
STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM
K952914 · LMD
Star Technologies, Inc.
Radiology · 84d
Cleared Sep 18, 1995
AUSCULATOR GPS
K953218 · DQD
Lyte Industries, Inc.
Cardiovascular · 70d
Cleared Sep 18, 1995
LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES
K953368 · BTR
Karl Storz Endoskop GmbH
Anesthesiology · 62d
Cleared Sep 18, 1995
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
K953464 · BYG
Westmed, Inc.
Anesthesiology · 56d
Cleared Sep 18, 1995
WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER
K953687 · CAH
Westmed Intl.
General Hospital · 42d
Cleared Sep 18, 1995
REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY
K953770 · ESD
Rexton, Inc.
Ear, Nose, Throat · 35d
Cleared Sep 18, 1995
UNICOR, INC. VENTILATOR HOSES
K953785 · BZO
Unicor, Inc.
Anesthesiology · 35d
Cleared Sep 18, 1995
PHONAK 9900 CIC
K953921 · ESD
Phonak, Inc.
Ear, Nose, Throat · 28d
Cleared Sep 18, 1995
MED-TECH LUNG DIFFUSION MIXTURE
K953934 · BXK
Medical Technical Gases Inc..
Anesthesiology · 31d
Cleared Sep 18, 1995
FLUORO CATHETER
K953950 · JAA
Cmt Medical Technologies, Ltd.
Radiology · 27d
Cleared Sep 18, 1995
LUMISYS, LUMISCAN 20
K953964 · LMA
Lumisys, Inc.
Radiology · 27d
Cleared Sep 18, 1995
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING...
K954038 · ESD
Argosy Electronics
Ear, Nose, Throat · 21d
Cleared Sep 15, 1995
ARTHREX SUTURE ANCHOR SCREW SYSTEM
K934327 · MBI
Arthrex, Inc.
Orthopedic · 742d
Cleared Sep 15, 1995
EBV-EA(D) IGG ELISA TEST
K940093 · LSE
Gull Laboratories, Inc.
Microbiology · 616d
Cleared Sep 15, 1995
VIDEO SCOPE SYSTEM (LARYNGOSCOPE)
K944032 · ENZ
Jedmed Instrument Co.
Ear, Nose, Throat · 394d
Cleared Sep 15, 1995
HI-Q HAND INSTRUMENTS, OB/GYN USE
K944200 · HET
Olympus America, Inc.
Obstetrics & Gynecology · 382d