Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
69745–69768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2004
MARK 5 NUVO (M5C5)
K032509 · CAW
Nidek Medical Products, Inc.
Anesthesiology · 217d
Cleared Mar 18, 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
K032850 · NBT
Immco Diagnostics, Inc.
Immunology · 188d
Cleared Mar 18, 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
K032860 · NBT
Immco Diagnostics, Inc.
Immunology · 188d
Cleared Mar 18, 2004
ARIOL
K033200 · NQN
Applied Imaging Corp.
Pathology · 168d
Cleared Mar 18, 2004
IVY DEVICES INC. IV/MEDICAL LINE STABILIZER
K033208 · FPA
Ivy Devices, Inc.
General Hospital · 168d
Cleared Mar 18, 2004
ZAP HCG TEST, MODEL 8001
K033297 · JHI
Zbx Corporation
Chemistry · 156d
Cleared Mar 18, 2004
IDI-MRSA
K033415 · NQX
Infectio Diagnostic (I.D.I.), Inc.
Microbiology · 143d
Cleared Mar 18, 2004
INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905
K040036 · MEG
Inviro Medical
General Hospital · 69d
Cleared Mar 18, 2004
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
K040073 · GKZ
Sysmex America, Inc.
Hematology · 64d
Cleared Mar 18, 2004
DUCERAM PLUS CERAMIC SYSTEM
K040420 · EIH
Dentsply Intl.
Dental · 29d
Cleared Mar 18, 2004
DUCERAGOLD PORCELAINS
K040421 · EIH
Dentsply Intl.
Dental · 29d
Cleared Mar 18, 2004
SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
K040481 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 22d
Cleared Mar 18, 2004
ELLIPTIC MATRIX
K040539 · NHA
Institut Straumann AG
Dental · 16d
Cleared Mar 18, 2004
ALICE 5
K040595 · OLZ
Respironics, Inc.
Neurology · 10d
Cleared Mar 18, 2004
VITALAB DIRECT BILIRUBIN REAGENT
K040631 · CIG
Clinical Data, Inc.
Chemistry · 8d
Cleared Mar 17, 2004
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K030624 · BSZ
Draeger Medical, Inc.
Anesthesiology · 384d
Cleared Mar 17, 2004
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K031142 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 195d
Cleared Mar 17, 2004
BIRD TBIRD VELA VENTILATOR
K032451 · CBK
Bird Products Corp.
Anesthesiology · 219d
Cleared Mar 17, 2004
GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM...
K032671 · MLY
Gebauer Co.
Physical Medicine · 201d
Cleared Mar 17, 2004
ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02
K032896 · FZP
Anson Medical , Ltd.
General & Plastic Surgery · 182d
Cleared Mar 17, 2004
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · QSY
Radi Medical Systems AB
General & Plastic Surgery · 155d
Cleared Mar 17, 2004
COLLAGEN DENTAL WOUND DRESSINGS
K033729 · LYC
Collagen Matrix, Inc.
Dental · 110d
Cleared Mar 17, 2004
CAAS II RVA
K033920 · LLZ
Pie Medical Imaging BV
Radiology · 90d
Cleared Mar 17, 2004
TH0R DDII IR LAMP SYSTEM
K033923 · ILY
Thor Intl.
Physical Medicine · 90d