FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95593–95616 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K964798 · ETB
Anthony D. Prescott
Ear, Nose, Throat · 34d
Cleared Jan 02, 1997
SPETEMP EF
K964809 · EMA
Ultradent Products, Inc.
Dental · 34d
Cleared Dec 31, 1996
OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM
K963184 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 139d
Cleared Dec 31, 1996
AS 123 PROSTHETIC INSTRUMENTATION SYSTEM
K963951 · DZE
BioHorizons Implant Systems, Inc.
Dental · 90d
Cleared Dec 31, 1996
INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
K964006 · ILO
Hollister, Inc.
Physical Medicine · 85d
Cleared Dec 31, 1996
TIELLE HYDROPOLYMER FOAM DRESSING
K964016 · KMF
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 85d
Cleared Dec 31, 1996
INCARE HOT/ICE SYSTEM SHOULDER BLANKET
K964057 · ILO
Hollister, Inc.
Physical Medicine · 83d
Cleared Dec 31, 1996
DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
K964070 · CAC
Deknatel, Inc.
Anesthesiology · 82d
Cleared Dec 31, 1996
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
K964127 · GCX
Allegiance Healthcare Corp.
General Hospital · 77d
Cleared Dec 31, 1996
TRUSLIFT PORCH LIFT
K964134 · ING
Trus T Lift
Physical Medicine · 77d
Cleared Dec 31, 1996
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1
K964145 · KOJ
Crystal Mark, Inc.
Dental · 75d
Cleared Dec 31, 1996
TAKI ACUPUNCTURE NEEDLES
K964411 · MQX
Lhasa Medical, Inc.
General Hospital · 83d
Cleared Dec 31, 1996
ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
K964515 · FNL
M.C. Healthcare Products, Inc.
General Hospital · 76d
Cleared Dec 30, 1996
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM
K955425 · LYY
Dash Medical Gloves Sdn Bhd
General Hospital · 398d
Cleared Dec 30, 1996
ACU-HALT
K955661 · LDQ
Glederer & Co., Inc.
General & Plastic Surgery · 384d
Cleared Dec 30, 1996
ISOLATION GOWN
K960999 · FYC
Copioumed Intl., Inc.
General Hospital · 293d
Cleared Dec 30, 1996
SHOE COVER, NON-STERILE
K961342 · FXP
Copioumed Intl., Inc.
General Hospital · 285d
Cleared Dec 30, 1996
INJECTO FLUSH
K964120 · FCL
Robert J. Jynch, Jr.
Gastroenterology & Urology · 76d
Cleared Dec 30, 1996
KROMALGIN IMPRESSION MATERIAL
K964177 · ELW
North American Orthodontic...
Dental · 73d
Cleared Dec 30, 1996
POWDER FREE VINYL EXAMINATION GLOVE
K964545 · LYZ
Shanghai Poseidon Plastic Products...
General Hospital · 47d
Cleared Dec 30, 1996
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K964563 · LYY
Omni Sales Corp.
General Hospital · 46d
Cleared Dec 27, 1996
CORAIL
K953111 · LZO
Landos, Inc.
Orthopedic · 543d
Cleared Dec 27, 1996
NEEDLE'S EYE SNARE
K961992 · DXE
Cook Pacemaker Corp.
Cardiovascular · 220d
Cleared Dec 27, 1996
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
K962309 · FJI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 193d