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
88129–88152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 22, 1998
INSTACINE D-2000
K983088 · LLZ
Fidelity Medical, Inc.
Radiology · 25d
Cleared Sep 22, 1998
MAGNATEK80
K983114 · CCK
Magna Advanced Technologies, Inc.
Anesthesiology · 18d
Cleared Sep 22, 1998
ELECSYS CALCHECK MYOGLOBIN
K983166 · JJY
Boehringer Mannheim Corp.
Chemistry · 12d
Cleared Sep 21, 1998
DIAMEDIX IS-CMV IGG TEST SYSTEM
K981163 · LFZ
Diamedix Corp.
Microbiology · 174d
Cleared Sep 21, 1998
UPRO
K981682 · JGQ
Abbott Laboratories
Chemistry · 131d
Cleared Sep 21, 1998
QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN...
K982152 · DIS
Phamatech
Toxicology · 95d
Cleared Sep 21, 1998
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K982394 · KLE
Dentsply Intl.
Dental · 74d
Cleared Sep 21, 1998
RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
K982767 · JIX
Raichem
Chemistry · 46d
Cleared Sep 18, 1998
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
K980816 · HQX
Fci Ophthalmics, Inc.
Ophthalmic · 199d