FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134137–134160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
K883649 · LNH
Instrumentarium Corp.
Radiology · 51d
Cleared Oct 19, 1988
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
K883713 · MSJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 50d
Cleared Oct 19, 1988
QM300 APOLIPOPROTEIN B ANTIBODY PACK
K883714 · MSJ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 50d
Cleared Oct 19, 1988
RADKOR SFR-70
K883864 · IYB
Radkor, Inc.
Radiology · 36d
Cleared Oct 19, 1988
RADKOR, RF-159
K883885 · KXJ
Radkor, Inc.
Radiology · 36d
Cleared Oct 19, 1988
AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)
K883915 · DBL
Immco Diagnostics, Inc.
Immunology · 33d
Cleared Oct 19, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A
K884040 · CZP
Orion Diagnostica, Inc.
Immunology · 23d
Cleared Oct 19, 1988
ELAN-E DISPOSABLE DRAPE
K884057 · KKX
Aesculap Instruments Corp.
General Hospital · 23d
Cleared Oct 19, 1988
IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
K884075 · DDG
Orion Diagnostica, Inc.
Immunology · 22d
Cleared Oct 19, 1988
STERILE DISPOSABLE SURGICAL PACKS
K884093 · LRO
Bolden Surgical Products
General & Plastic Surgery · 21d
Cleared Oct 19, 1988
SCISSORS, WIRE CUTTING
K884095 · LRW
Magnatrade Corp.
General & Plastic Surgery · 21d
Cleared Oct 19, 1988
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
K884101 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 63d
Cleared Oct 19, 1988
FLOSER PLUS
K884145 · JES
Pacific Lin Intl., Co.
Dental · 16d
Cleared Oct 18, 1988
DENTAL ANTI-SNORING DEVICE
K874416 · LRK
Ortho Publications, Inc.
Dental · 356d
Cleared Oct 18, 1988
DIACARE MONITORING SYSTEM
K882001 · NDC
Healthware Corp.
General Hospital · 159d
Cleared Oct 18, 1988
NICOLET EPIDURAL SPINAL ELECTRODE
K882053 · GYC
Nicolet Instrument Corp.
Neurology · 155d
Cleared Oct 18, 1988
NEBULIZER PUMP POWERED MODELS 020 AND 050
K883132 · BTI
Travelneb, Inc.
Anesthesiology · 84d
Cleared Oct 18, 1988
DISPOSABLE AMNIOTOME
K883283 · HGG
Galenica Enterprises, Inc.
Obstetrics & Gynecology · 75d
Cleared Oct 18, 1988
LUMINBOND, BONDING AND CEMENTATION SYSTEM
K883392 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 70d
Cleared Oct 18, 1988
CLOSED WOUND SUCTION DEVICE
K883472 · GCY
Westmark, Sterile Packing Systems,...
General & Plastic Surgery · 63d
Cleared Oct 18, 1988
ULTRACARE
K883633 · DWL
Jobst Institute, Inc.
General Hospital · 54d
Cleared Oct 18, 1988
QUIDEL ALLERGY SCREEN
K883666 · DHB
Quidel Corp.
Immunology · 53d
Cleared Oct 18, 1988
INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM
K883719 · LQJ
Biophysic Medical, Inc.
Ophthalmic · 48d
Cleared Oct 18, 1988
ARTERIAL ANCHOR BANDAGE
K883957 · FMK
Guidelines, Inc.
General & Plastic Surgery · 29d