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
114409–114432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1993
DORNIER FIBERTOME 100 WATT SURGICAL LASER
K921549 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 323d
Cleared Feb 18, 1993
COMPEL O AND R
K921889 · FYA
Standard Textile Co., Inc.
General Hospital · 302d
Cleared Feb 18, 1993
HYGIENEX EXAMINATION GLOVES
K922903 · LYY
Hygienex Corp.
General Hospital · 247d
Cleared Feb 18, 1993
LOS ALAMOS RETRACTABLE KNIFE
K923170 · GES
Innovative Surgical Technology, Inc.
General & Plastic Surgery · 234d
Cleared Feb 18, 1993
ECG ELECTRODE
K923558 · DRX
Lectec Corp.
Cardiovascular · 216d
Cleared Feb 18, 1993
BETAMIST 2
K923698 · CAF
Rantran, Inc.
Anesthesiology · 209d
Cleared Feb 18, 1993
STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
K924354 · DTW
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 190d
Cleared Feb 18, 1993
MIDKIFF GEOSTATIC CLAMP
K925035 · FWZ
D.L. Nelson and Assoc., Inc.
General & Plastic Surgery · 136d
Cleared Feb 18, 1993
DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE
K925855 · BTR
Coast Medical Corp.
Anesthesiology · 93d
Cleared Feb 18, 1993
NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K925906 · JJX
Analytical Control Systems, Inc.
Chemistry · 90d
Cleared Feb 18, 1993
SYNERMED SINGLE REAGENT CREATININE KIT
K926511 · CGX
Synermed, Inc.
Chemistry · 50d
Cleared Feb 17, 1993
CAMSYS 6300
K920574 · EXQ
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 376d
Cleared Feb 17, 1993
AMBULATORY (HOLTER) RECORDING, MODIFICATION
K922027 · DSI
Biosensor Corp.
Cardiovascular · 328d
Cleared Feb 17, 1993
TANDEM-E IGE II CALIBRATION VERIFICATION SET
K922754 · JJX
Hybritech, Inc.
Immunology · 254d
Cleared Feb 17, 1993
OSTEOMED M3 SYSTEM (SBF SYSTEM)
K924138 · JEY
Osteomed Corp.
Dental · 183d
Cleared Feb 17, 1993
COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT
K925438 · JOH
Aga Medical Products, Inc.
Anesthesiology · 112d
Cleared Feb 17, 1993
OXYSHUTTLE II ,MODIFICATION
K925542 · DQA
Sensor Medics Corp.
Anesthesiology · 121d
Cleared Feb 17, 1993
VITA CEREC DUO CEMENT
K925713 · EMA
Vident
Dental · 97d
Cleared Feb 17, 1993
VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
K926342 · JHI
Syva Co.
Chemistry · 62d
Cleared Feb 17, 1993
ORC ENDOSCOPIC INSTRUMENT HOLDER
K930399 · MDM
O.R. Concepts, Inc.
General & Plastic Surgery · 22d
Cleared Feb 16, 1993
SUNGLASSES
K914618 · HQY
La Salle Imports, Inc.
Ophthalmic · 489d
Cleared Feb 16, 1993
BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT.
K922939 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 243d
Cleared Feb 16, 1993
SURGICAL GOWN
K922949 · FYA
Robert J. Sislian, Inc.
General Hospital · 243d
Cleared Feb 16, 1993
CORNEAL TOPOGRAPHY SYSTEM
K923435 · HLQ
Par Microsystems Corp.
Ophthalmic · 218d