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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
99025–99048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1996
RETRACTOR ARM CLAMP
K960019 · FWZ
Biopsys Medical, Inc.
General & Plastic Surgery · 38d
Cleared Feb 08, 1996
INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM
K943604 · DZE
Calcitek, Inc.
Dental · 563d
Cleared Feb 08, 1996
PERITRON
K945611 · HIR
Cardio Design Pty. , Ltd.
Gastroenterology & Urology · 450d
Cleared Feb 08, 1996
ABRM CATHETER
K950118 · FOZ
Cook, Inc.
General Hospital · 393d
Cleared Feb 08, 1996
MODEL #7354
K950849 · BZD
Devilbiss Health Care, Inc.
Anesthesiology · 349d
Cleared Feb 08, 1996
ACUFEX ENDOBUTTON TAPE
K952535 · GAT
Acufex Microsurgical, Inc.
General & Plastic Surgery · 252d
Cleared Feb 08, 1996
MISTASSIST BREATHING EXERCISER
K953055 · BWF
The Merlin Corp.
Anesthesiology · 223d
Cleared Feb 08, 1996
MS CLASSIQUE BALLOON DIATATION CATHETER
K953298 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 209d
Cleared Feb 08, 1996
LOS 3D VISION 100
K953419 · GCJ
Laser Optik Systeme GmbH & Co. KG
General & Plastic Surgery · 220d
Cleared Feb 08, 1996
MEDI-FRIG
K954703 · GEH
Ellman Intl., Inc.
General & Plastic Surgery · 119d
Cleared Feb 08, 1996
BACTEC PEDS PLUS CLUTURE VIALS
K954924 · MDB
Becton Dickinson Diagnostic...
Microbiology · 105d
Cleared Feb 08, 1996
VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION)
K955083 · GEH
Cryosurgery, Inc.
General & Plastic Surgery · 136d
Cleared Feb 08, 1996
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER
K955160 · IRO
Everapex Design & Marketing Corp.
Physical Medicine · 87d
Cleared Feb 08, 1996
SURGITRON
K955167 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 87d
Cleared Feb 08, 1996
QI GONG MASSAGER
K955250 · IRO
East Health Development Group, Inc.
Physical Medicine · 87d
Cleared Feb 08, 1996
COULTER LINEARITY CONTROL
K955334 · JPK
Coulter Corp.
Hematology · 80d
Cleared Feb 08, 1996
DURALASTIC I
K955368 · MIB
Allied Biomedical Corp.
General & Plastic Surgery · 78d
Cleared Feb 08, 1996
DURALASTIC II
K955370 · MIB
Allied Biomedical Corp.
General & Plastic Surgery · 78d
Cleared Feb 08, 1996
ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER
K955413 · FGE
Endovations
Gastroenterology & Urology · 73d
Cleared Feb 08, 1996
3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955428 · DZE
Implant Innovations, Inc.
Dental · 72d
Cleared Feb 08, 1996
CARIES FINDER
K955445 · LFC
Danville Engineering, Inc.
Dental · 71d
Cleared Feb 08, 1996
ADJUSTABLE PM POSITIONER
K955503 · LQZ
Jonathan A. Parker, D.D.S.
Dental · 69d
Cleared Feb 08, 1996
SHORTSTOP DISPOSABLE PROPHY ANGLE
K955654 · EFB
Spintech, Inc.
Dental · 58d
Cleared Feb 08, 1996
AARON 800 HIGH FREQUENCY DESICCATOR/HANDPIECE
K955681 · GEI
Geiger Instrument Co., Inc.
General & Plastic Surgery · 56d