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
88633–88656 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1998
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
K980930 · LFL
Fibra Sonics, Inc.
General & Plastic Surgery · 194d
Cleared Sep 22, 1998
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH...
K981260 · HDB
Clinical Innovations, Inc.
Obstetrics & Gynecology · 169d
Cleared Sep 22, 1998
VTEC-RPLA SEIKEN
K981734 · GNA
Denka Seiken'S
Microbiology · 127d
Cleared Sep 22, 1998
ALM PRISMALIX (PRX) SURGICAL LIGHT
K982063 · FSY
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 102d
Cleared Sep 22, 1998
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM
K982073 · GCJ
Anchor Products Co.
General & Plastic Surgery · 102d
Cleared Sep 22, 1998
PREMIER AP
K982221 · GZJ
American Imex
Neurology · 90d
Cleared Sep 22, 1998
CHROMA ZONE COLOR STAIN
K982259 · EBF
Kuraray America, Inc.
Dental · 88d
Cleared Sep 22, 1998
WAKO DIRECT LDL-C
K982271 · MRR
Wako Chemicals USA, Inc.
Chemistry · 85d
Cleared Sep 22, 1998
SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT
K982305 · DZE
Sulzer Calcitek, Inc.
Dental · 83d
Cleared Sep 22, 1998
POLYTUBE
K982306 · MGQ
Ferris Mfg. Corp.
General & Plastic Surgery · 83d
Cleared Sep 22, 1998
CAREGRAPH
K982319 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Sep 22, 1998
BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
K982403 · PAG
Brennen Medical, Inc.
Gastroenterology & Urology · 74d
Cleared Sep 22, 1998
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
K982475 · FTL
Tissue Technologies, Inc.
General & Plastic Surgery · 68d
Cleared Sep 22, 1998
STRYKER URETERAL ILLUMINATOR SYSTEM III
K982542 · FCS
Stryker Endoscopy
Gastroenterology & Urology · 63d
Cleared Sep 22, 1998
PHASER-2000
K982546 · ILY
Diomedics, Inc.
Physical Medicine · 63d
Cleared Sep 22, 1998
OSTEO COMPRESSION HIP SCREW SYSTEM
K982553 · HRS
Osteonics Corp.
Orthopedic · 62d
Cleared Sep 22, 1998
EASY TRANS TIP
K982565 · KXO
Carl Schuh
Obstetrics & Gynecology · 61d
Cleared Sep 22, 1998
KSEA FLIPPTACK
K982571 · MBI
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 60d
Cleared Sep 22, 1998
ECTON LYNX ULTRASOUND SYSTEM
K982800 · IYO
Ecton, Inc.
Radiology · 43d
Cleared Sep 22, 1998
BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K982802 · GKZ
Bayer Corp.
Hematology · 43d
Cleared Sep 22, 1998
ASCENT SYSTEM
K982869 · JWH
Biomet, Inc.
Orthopedic · 39d
Cleared Sep 22, 1998
VACUTAINER BRAND BLOOD COLLECTION SYRINGE
K982922 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 34d
Cleared Sep 22, 1998
DUAL PURPOSE CLOSED CATHETER
K982945 · BSY
Spirit Medical Systems, Inc.
Anesthesiology · 32d
Cleared Sep 22, 1998
MODIFICATION TO SYSTEM 83 PLUS
K983017 · NVE
Custom Ultrasonics
General Hospital · 25d