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

118 results for "Hologic, Inc."

97–118 of 118

Search insights Median review: 87d Cleared: 98% Top manufacturer: Hologic, Inc. Lead specialty: Radiology

Cleared Oct 16, 2003

HOLOGIC DR IMAGEPRO

Radiology · 59d

Cleared Nov 08, 2002

HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY

Radiology · 30d

Cleared Sep 28, 2000

HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND...

Radiology · 28d

Cleared Oct 01, 1999

OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...

Radiology · 44d

Cleared Sep 03, 1999

EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...

Radiology · 24d

Cleared Nov 13, 1998

FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000,...

Radiology · 74d

Cleared Jan 12, 1998

FS IV MINI C-ARM SYSTEM

Radiology · 77d

Cleared Jun 13, 1997

BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS

Radiology · 400d

Cleared Nov 22, 1996

HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS

Radiology · 87d

Cleared Aug 30, 1995

BONE MINERAL DENSITOMETER

Radiology · 527d

Cleared Jan 20, 1995

HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER

Radiology · 184d

Cleared Jul 23, 1993

Radiology · 221d

Cleared Nov 01, 1991

HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER

Radiology · 99d

Cleared Oct 30, 1991

HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST

Radiology · 70d

Cleared Jun 10, 1991

QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER

Radiology · 168d

Cleared May 15, 1991

QDR-1000 AND WITH X-RAY BONE DENSITOMETER

Radiology · 147d

Cleared Aug 30, 1990

HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER

Radiology · 406d

Cleared Dec 21, 1989

MODIFIED QDR-1000 X-RAY BONE DENSITOMETER

Radiology · 297d

Cleared Sep 29, 1988

HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED

Radiology · 57d

Cleared Sep 27, 1988

HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM

Radiology · 49d

Cleared Oct 20, 1987

HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1

Radiology · 190d

Cleared Oct 08, 1987

X-CALIBER MODEL 1000 BONE MINERAL ANALYZER

Radiology · 169d