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
133537–133560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1988
STAR ALLOYS, LITE ALLOYS AND BRITE ALLOYS
K882532 · EJT
Five Stars Alloys , Ltd.
Dental · 120d
Cleared Oct 19, 1988
VISIO-PERL
K882566 · EBF
Espe GmbH (Us)
Dental · 119d
Cleared Oct 19, 1988
NICOLET BRAINLAB SYSTEM
K882599 · GWK
Nicolet Instrument Corp.
Neurology · 117d
Cleared Oct 19, 1988
NORMOCAP 200 CAPNOMETER
K882748 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 106d
Cleared Oct 19, 1988
DATEX AIRWAY MONITOR
K882885 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 100d
Cleared Oct 19, 1988
OHMEDA CONTINUOUS SUCTION REGULATOR
K883229 · KDP
Ohmeda Medical
General Hospital · 79d
Cleared Oct 19, 1988
VISTA MR 2055 HP SYSTEM
K883482 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 64d
Cleared Oct 19, 1988
FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)
K883519 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Oct 19, 1988
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540 · KTN
Unipath , Ltd.
Immunology · 62d
Cleared Oct 19, 1988
BETA 3000M MOBILE NMR IMAGING SYSTEM
K883648 · LNH
Fonar Corp.
Radiology · 50d
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