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
95569–95592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1996
LATEX EXAMINATION GLOVES, POWDERED
K963742 · LYY
Arista Medi Prima
General Hospital · 64d
Cleared Nov 20, 1996
COOL-ZONE
K963809 · FYA
Kappler USA
General Hospital · 58d
Cleared Nov 20, 1996
CEDIA PHENYTOIN II ASSAY
K963840 · DIP
Boehringer Mannheim Corp.
Toxicology · 57d
Cleared Nov 20, 1996
RDI LDL PRECIPITATION REAGENT
K964063 · MRR
Reference Diagnostics, Inc.
Chemistry · 41d
Cleared Nov 20, 1996
RDI LIPIDIRECT MAGNETIC LDL REAGENT
K964064 · MRR
Reference Diagnostics, Inc.
Chemistry · 41d
Cleared Nov 20, 1996
PALLADIA 75 (PM-11)
K964466 · EJT
Gateway Alloys, Inc.
Dental · 13d
Cleared Nov 19, 1996
BIFURCATED Y-EXTENSION
K953742 · GZB
Medtronic Vascular
Neurology · 469d
Cleared Nov 19, 1996
KOH COLPOTOMIZER SYSTEM
K954311 · HEW
CooperSurgical, Inc.
Obstetrics & Gynecology · 431d
Cleared Nov 19, 1996
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
K955835 · FXP
Instrument Makar, Inc.
General Hospital · 329d
Cleared Nov 19, 1996
ANSPAHC SPEED REDUCER
K960630 · HBB
The Anspach Effort, Inc.
Neurology · 284d
Cleared Nov 19, 1996
MATCHMAKER/PROPAQUE PORCELAIN
K960770 · ELL
Davis Schottlander & Davis, Ltd.
Dental · 267d
Cleared Nov 19, 1996
LWEET CONE BIOPSY INSTRUMENT
K961460 · HGI
Apple Medical Corp.
Obstetrics & Gynecology · 217d
Cleared Nov 19, 1996
UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG...
K961906 · EYZ
Spectrum Medsystems Corp.
Gastroenterology & Urology · 187d
Cleared Nov 19, 1996
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K961999 · DYG
Boston Scientific Scimed, Inc.
Cardiovascular · 181d
Cleared Nov 19, 1996
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX...
K962096 · LYY
Medline Industries, Inc.
General Hospital · 175d
Cleared Nov 19, 1996
MIDAS REX III MOTOR
K962483 · HBB
Midas Rex Pneumatic Tools, Inc.
Neurology · 146d
Cleared Nov 19, 1996
CARDIOSERV S
K962551 · LDD
Marquette Electronics, Inc.
Cardiovascular · 144d
Cleared Nov 19, 1996
BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
K962771 · DWS
Pilling Weck, Inc.
Cardiovascular · 126d
Cleared Nov 19, 1996
KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
K962863 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 119d
Cleared Nov 19, 1996
MEDI-TRACE 5700 RESTING ECG ELECTRODE
K963151 · DRX
Graphic Controls Corp.
Cardiovascular · 102d
Cleared Nov 19, 1996
POSEY LAPTOP TRAYS
K963411 · FMQ
J. T. Posey Co.
General Hospital · 81d
Cleared Nov 19, 1996
PELVIC HOLDERS
K963437 · FMQ
J. T. Posey Co.
General Hospital · 81d
Cleared Nov 19, 1996
PEDIATRIC LIMB HOLDERS
K963439 · FMQ
J. T. Posey Co.
General Hospital · 81d
Cleared Nov 19, 1996
BARD HIGH FLOW PAPILLOTOME
K963484 · KNS
Bard Interventional Products Div.
Gastroenterology & Urology · 77d