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
98833–98856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1996
BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS
K955485 · DQO
B.Braun Medical, Inc.
Cardiovascular · 84d
Cleared Feb 23, 1996
URIC ACID CATALOGE# 220-93/94/97
K955496 · KNK
Diagnostic Chemicals , Ltd.
Chemistry · 84d
Cleared Feb 23, 1996
REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
K955669 · JTN
Remel Co.
Microbiology · 72d
Cleared Feb 23, 1996
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K955910 · JWY
Dade Microscan, Inc.
Microbiology · 56d
Cleared Feb 22, 1996
GLUCOCHEK POCKETLAB
K951457 · CGA
Clinical Diagnostics, Inc.
Chemistry · 330d
Cleared Feb 22, 1996
ATI ETHYLENE OXIDE STERILIZATION INDICATOR
K952995 · JOJ
Pymah Corp.
General Hospital · 239d
Cleared Feb 22, 1996
TRINITY SLEEVE(S)
K954489 · JOW
Delphi Consulting Group
Cardiovascular · 148d
Cleared Feb 22, 1996
POLYFIN QR SUBCUTANEOUS INFUSION SET
K954969 · FPA
Medtronic Minimed
General Hospital · 115d
Cleared Feb 22, 1996
STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER
K955152 · DTW
Stoeckert Instrumente
Cardiovascular · 101d
Cleared Feb 22, 1996
OES LAPARO-THORACO VIDEOSCOPE (RIGID)
K955456 · HET
Olympus America, Inc.
Obstetrics & Gynecology · 85d
Cleared Feb 22, 1996
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
K955599 · GDY
Stryker Corp.
General & Plastic Surgery · 76d
Cleared Feb 22, 1996
SONATA U-01
K955702 · ESD
Electone, Inc.
Ear, Nose, Throat · 69d
Cleared Feb 22, 1996
THE E TEST CEFTIZOXIME
K955920 · JWY
Ab Biodisk
Microbiology · 113d
Cleared Feb 21, 1996
RIA LATEX CONDOM, NONOXYNOL-9
K945145 · HIS
Mbf Personal Care Sdn. Bhd.
Obstetrics & Gynecology · 489d
Cleared Feb 21, 1996
VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE)
K952238 · LMB
Imaging Concepts, Inc.
Radiology · 285d
Cleared Feb 21, 1996
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
K952884 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 243d
Cleared Feb 21, 1996
SPINE SYSTEM SACRAL PLATE
K953881 · MNH
J.B.S., S.A.
Orthopedic · 187d
Cleared Feb 21, 1996
ASTECH PEAK FLOW METER
K954277 · BZH
Center Laboratories, Inc.
Anesthesiology · 163d
Cleared Feb 21, 1996
DICOMVIEW
K954479 · LMD
Heartlab, Inc.
Radiology · 148d
Cleared Feb 21, 1996
STOCKERT S3 DOUBLE HEAD PUMP MODULE
K955038 · DWB
Stoeckert Instrumente
Cardiovascular · 110d
Cleared Feb 21, 1996
INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM
K955041 · ESW
Instent, Inc.
Gastroenterology & Urology · 110d
Cleared Feb 21, 1996
ECOGEL 200 ULTRASOUND GEL
K955246 · ITX
Eco-Med Pharmaceuticals, Inc.
Radiology · 98d
Cleared Feb 21, 1996
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
K955381 · DXT
B.Braun Medical, Inc.
Cardiovascular · 89d
Cleared Feb 21, 1996
SIENET TELERADIOLOGY PRODUCT LINE
K955394 · LMC
Siemens Medical Solutions USA, Inc.
Radiology · 89d