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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
152161–152184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1984
ALINE ORTHODONTIC ARCHWIRE
K841638 · DZC
A Company, Inc.
Dental · 68d
Cleared Jun 27, 1984
FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE
K841675 · JES
Leonard Lorch
Dental · 65d
Cleared Jun 27, 1984
IMR-90-DIPLOID-HUMAN FETAL LUNG CELL
K841998 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 42d
Cleared Jun 27, 1984
MONTGOMERY LARYNGEAL STENT
K842287 · FWN
Boston Medical Products, Inc.
Ear, Nose, Throat · 12d
Cleared Jun 27, 1984
EXACTA-FILM
K842512
Ardent Intl., Inc.
Dental
Cleared Jun 26, 1984
SPIROTECH ST-550
K840972 · BZG
Spirotech, Inc.
Anesthesiology · 112d
Cleared Jun 26, 1984
PULSE GENERATOR 728, 728B & 728L
K841226 · DXY
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 26, 1984
PULSE GENERATOR 718B & 718L
K841228 · DXY
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 26, 1984
PULSE GENERATOR 688B & 688L
K841231 · DXY
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 26, 1984
UNIMACS, PATENT PENDING UNIVERSAL MAM
K841774 · IZH
Technical Devices For Medicine
Radiology · 57d
Cleared Jun 26, 1984
PARA 4
K842017 · JPK
Streck Laboratories, Inc.
Hematology · 39d
Cleared Jun 26, 1984
PARAPLAST EXTRA TISSUE EMBEDDING MED.
K842053 · KEO
Sherwood Medical Co.
Pathology · 35d
Cleared Jun 26, 1984
GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY
K842079 · CGC
Immuno Nuclear Corp.
Chemistry · 34d
Cleared Jun 26, 1984
WAKO B.G. PRETEST STRIPS
K842207 · CGA
Healthdyne, Inc.
Chemistry · 22d
Cleared Jun 26, 1984
MELOY AUTOANTIBODY TEST SYS
K842247 · DBM
Meloy Laboratories, Inc.
Immunology · 20d
Cleared Jun 26, 1984
ZINC DUST SUSPENSION
K842299 · JSF
Irvine Diagnostic Services
Microbiology · 15d
Cleared Jun 26, 1984
CAPNOMETER
K842325 · CCK
Sensors, Inc.
Anesthesiology · 13d
Cleared Jun 26, 1984
PENLON TRANSPORT VENTILATOR SERIES 350
K842362 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 11d
Cleared Jun 26, 1984
PENLON ANESTHESIA VENTILATOR SERIES 300
K842363 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 11d
Cleared Jun 26, 1984
SPIROMATE AS-500
K842372 · BZG
Riko Medical & Scientific Instrument...
Anesthesiology · 11d
Cleared Jun 26, 1984
AVATRON DISPOSABLE I.P.P.B. CIRUCIT
K842389 · BZO
Avatron, Inc.
Anesthesiology · 8d
Cleared Jun 26, 1984
MODEL 4000 MD-YAG LASER FOR MALIGNANT
K842412 · HQF
Cooper Lasersonics, Inc.
Ophthalmic · 7d
Cleared Jun 25, 1984
LYRIS MODULAR INFO SYSTEM
K831830 · JQP
Biovation, Inc.
Chemistry · 384d
Cleared Jun 25, 1984
ULTRAMAX
K832705 · LIF
Medicorp, Inc.
Gastroenterology & Urology · 318d