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
100945–100968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1995
OXBORO-MEDICAL PIN COVERS
K952783 · LRN
Oxboro Medical Intl., Inc.
Orthopedic · 88d
Cleared Sep 15, 1995
HARVARD 2 SYRINGE PUMP
K952794 · FRN
Harvard Apparatus, Inc.
General Hospital · 88d
Cleared Sep 15, 1995
CUFF GUARD
K952825 · DXQ
Bowen Medical Services, Inc.
Cardiovascular · 87d
Cleared Sep 15, 1995
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K952831 · HWC
Linvatec Corp.
Orthopedic · 87d
Cleared Sep 15, 1995
PTFE SYRINGE FILTER
K952918 · FMF
B.Braun Medical, Inc.
General Hospital · 81d
Cleared Sep 15, 1995
PLASTIC BLUNT CANNULA
K952976 · FPA
Marquette Medical, Inc.
General Hospital · 80d
Cleared Sep 15, 1995
HYDROPHILIC FOAM DRESSING
K953019 · KMF
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 78d
Cleared Sep 15, 1995
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
K953039 · BYG
Dadsun Corp., Ltd.
Anesthesiology · 94d
Cleared Sep 15, 1995
PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE...
K953237 · DZE
The Implant Center of the Palm Beaches
Dental · 66d
Cleared Sep 15, 1995
HA, TP CYLINDER, UNIHOLE
K953280 · DZE
Implant Center of the Palm Beaches
Dental · 64d
Cleared Sep 15, 1995
HA, TP CYLINDER OVAL
K953281 · DZE
Implant Center of the Palm Beaches
Dental · 64d
Cleared Sep 15, 1995
PM POSITIONER
K953293 · LQZ
Jonathan A. Parker, D.D.S.
Dental · 63d
Cleared Sep 15, 1995
9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS
K953386 · JEY
Implant Innovations, Inc.
Dental · 58d
Cleared Sep 15, 1995
MIDAS REX TELESCOPING SYSTEM
K953433 · GET
Midas Rex Pneumatic Tools, Inc.
General & Plastic Surgery · 56d
Cleared Sep 15, 1995
GENERICUFF
K953466 · DXQ
Generic Medical, Inc.
Cardiovascular · 53d
Cleared Sep 15, 1995
WESTMED RESPIRATORY LUER ADAPTOR
K953506 · BXY
Westmed Intl.
Anesthesiology · 51d
Cleared Sep 15, 1995
HEAT MOISTURE EXCHANGER
K953580 · BYD
Intertech Resources, Inc.
Anesthesiology · 45d
Cleared Sep 15, 1995
DEXIDE ENDO-LUBE KIT
K953611 · GCJ
Dexide, Inc.
General & Plastic Surgery · 44d
Cleared Sep 15, 1995
MAXXUS ORTHOPAEDIC SURGICAL GLOVES
K953641 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 42d
Cleared Sep 15, 1995
PRENVAL I
K953652 · JQP
Base Ten Systems, Inc.
Immunology · 39d
Cleared Sep 15, 1995
DYONICS DISPOSABLE ARTHROSCOPIC BLADES
K953695 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 38d
Cleared Sep 15, 1995
LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY...
K953926 · DCK
International Enzymes, Inc.
Immunology · 31d
Cleared Sep 15, 1995
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN...
K953927 · DCF
International Enzymes, Inc.
Immunology · 31d
Cleared Sep 15, 1995
BIOACCESS BONE BIOPSY SYSTEM
K954151 · KNW
Bioaccess, Inc.
Gastroenterology & Urology · 10d