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
96073–96096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1996
THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK,...
K962749 · BWF
Diemolding Corp.
Anesthesiology · 87d
Cleared Oct 10, 1996
4F NYLEX ANGIOGRAPHIC CATHETER
K962759 · DQO
Cordis Corp.
Cardiovascular · 86d
Cleared Oct 10, 1996
AIRSEP IMPULSE
K962766 · NFB
Airsep Corp.
Anesthesiology · 86d
Cleared Oct 10, 1996
ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
K962926 · MID
American Laboratory Products Co., Ltd.
Immunology · 73d
Cleared Oct 10, 1996
DEODORANT PANTY SHIELD
K962953 · HHL
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 72d
Cleared Oct 10, 1996
DEODORANT MAXI PAD
K962954 · HHL
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 72d
Cleared Oct 10, 1996
DEODORANT PANTY LINER
K962962 · HHL
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 72d
Cleared Oct 10, 1996
ED-3410, VIDEO DUODENOSCOPE
K963056 · FDT
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 65d
Cleared Oct 10, 1996
EXTREMITY BONE SCREW
K963118 · HWC
Acu Med, Inc.
Orthopedic · 59d
Cleared Oct 10, 1996
VIDAMED RF GENERATOR DATA RECORDER
K963180 · GEI
Vidamed, Inc.
General & Plastic Surgery · 57d
Cleared Oct 10, 1996
TEMPRA COLD PACK, REORDER NO. TC150
K963220 · IMD
Tempo Technology, Inc.
Physical Medicine · 55d
Cleared Oct 10, 1996
BIOPSY INTRODUCER NEEDLE
K963390 · KNW
Baxter Healthcare Corp
Gastroenterology & Urology · 43d
Cleared Oct 10, 1996
ALTA FULLY THREADED CROSS-LOCKING SCREWS
K963398 · HWC
Howmedica Corp.
Orthopedic · 42d
Cleared Oct 10, 1996
SIGMA DIAGNOSTICS CALICIUM REAGENT
K963536 · CJY
Sigma Diagnostics, Inc.
Chemistry · 37d
Cleared Oct 10, 1996
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
K963752 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 22d
Cleared Oct 09, 1996
BARD V-MAX ROLLER BAR (3551XX
K961841 · FAS
C.R. Bard, Inc.
Gastroenterology & Urology · 149d
Cleared Oct 09, 1996
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K962006 · HQD
Menicon Co, Ltd.
Ophthalmic · 140d
Cleared Oct 09, 1996
MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET
K962707 · KDI
Minntech Corp.
Gastroenterology & Urology · 89d
Cleared Oct 09, 1996
THE L-BOW ARM RESTRAINT
K962778 · FMQ
Heelbo, Inc.
General Hospital · 84d
Cleared Oct 09, 1996
GREAT HANDS MITTS
K962810 · FMQ
Heelbo, Inc.
General Hospital · 83d
Cleared Oct 09, 1996
ANESTHESIA CONDUCTION NEEDLE
K962886 · BSP
Ispg, Inc.
Anesthesiology · 77d
Cleared Oct 09, 1996
BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER
K962921 · EZN
C.R. Bard, Inc.
Gastroenterology & Urology · 75d
Cleared Oct 09, 1996
OPUS CMV TEST SYSTEM-MODIFICATION
K963084 · LFZ
Behring Diagnostics, Inc.
Microbiology · 62d
Cleared Oct 09, 1996
HEELBO QUILTED TORSO RESTRAINT
K963108 · FMQ
Hollister, Inc.
General Hospital · 58d