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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68401–68424 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 17, 2004
RTIST
K033955 · LLZ
Mirada Solutions , Ltd.
Radiology · 86d
Cleared Mar 17, 2004
NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM
K040039 · LLZ
Barco N.V.
Radiology · 68d
Cleared Mar 17, 2004
PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS...
K040119 · FTM
Synovis Surgical Innovations
General & Plastic Surgery · 57d
Cleared Mar 17, 2004
DERMAWAVE 5000 COMBI MAX SYSTEM
K040121 · IMG
Dermawave, LLC
Physical Medicine · 57d
Cleared Mar 17, 2004
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING...
K040408 · LYY
Shun Thai Rubber Gloves Industry...
General Hospital · 29d
Cleared Mar 17, 2004
VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD
K040510 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 19d
Cleared Mar 17, 2004
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
K040538 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 15d
Cleared Mar 17, 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040558 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 14d