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
88537–88560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1998
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
K982249 · EWO
Idem (Int'L Dist. of Electronics For...
Ear, Nose, Throat · 42d
Cleared Aug 07, 1998
MICRO21 WITH URINE SEDIMENT ANALYSIS
K982301 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 37d
Cleared Aug 07, 1998
DIAGNOSTIC ULTRASOUND SYSTEM
K982498 · IYN
Volumetrics Medical Imaging, Inc.
Radiology · 21d
Cleared Aug 07, 1998
CAREDOP II
K982635 · JAF
Nicolet Biomedical
Radiology · 25d
Cleared Aug 07, 1998
MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982686 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 4d
Cleared Aug 06, 1998
SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM
K974539 · MNT
Resmed, Ltd.
Anesthesiology · 246d
Cleared Aug 06, 1998
5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE...
K974847 · MBI
Arthrex, Inc.
Orthopedic · 220d
Cleared Aug 06, 1998
MINI-CISER
K974848 · BWF
Hougen Mfg., Inc.
Anesthesiology · 220d
Cleared Aug 06, 1998
X-AIR-CISER
K974849 · BYI
Hougen Mfg., Inc.
Anesthesiology · 220d
Cleared Aug 06, 1998
IMAGE VUE EEG
K980477 · OLX
Sam Technology, Inc.
Neurology · 181d
Cleared Aug 06, 1998
GC IRRIGATOR
K980868 · KPL
Gentle Colonics, Inc.
Gastroenterology & Urology · 153d
Cleared Aug 06, 1998
TOXOGEN
K981263 · GMM
Instrumentation Laboratory CO
Microbiology · 121d
Cleared Aug 06, 1998
DBEST AMPHETAMINES TEST KIT
K981504 · DKZ
Ameritek, Inc.
Toxicology · 101d
Cleared Aug 06, 1998
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K981684 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 85d
Cleared Aug 06, 1998
BISSINGER CABLES, CAT. NO. 801000XX
K981919 · GEI
Guenter Bissinger Medizintechnik GmbH
General & Plastic Surgery · 66d
Cleared Aug 06, 1998
GALILEO DISPOSABLE ENDOSCOPES
K981928 · GCJ
Galileo Electro-Optics Corp.
General & Plastic Surgery · 65d
Cleared Aug 06, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982011 · KWP
DePuy Orthopaedics, Inc.
Orthopedic · 59d
Cleared Aug 06, 1998
SILON SCAR STRIPS
K982036 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 57d
Cleared Aug 06, 1998
ASLAN SENSOR MODULAR INSTRUMENT
K982287 · GCJ
Aslan Medical Technologies, Ltd.
General & Plastic Surgery · 37d
Cleared Aug 06, 1998
NIDEK LIGHTSCAN
K982295 · GEX
Nidek, Inc.
General & Plastic Surgery · 36d
Cleared Aug 06, 1998
DISETRONIC PENFINE INJECTION PEN NEEDLE
K982399 · FMI
Disetronic Medical Systems
General Hospital · 27d
Cleared Aug 06, 1998
B2-MICROGLOBULIN CONTROL SET SERUM
K982471 · JJX
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Aug 05, 1998
CT 200 ELECTROCARDIOGRAPH
K961798 · DPS
Macquarie Medical Systems
Cardiovascular · 818d
Cleared Aug 05, 1998
BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651
K971892 · JOW
Biomedical Horizons, Inc.
Cardiovascular · 440d