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
87841–87864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1998
BIODERM FOAM WOUND DRESSING
K982778 · KMF
Bioderm, Inc.
General & Plastic Surgery · 75d
Cleared Oct 21, 1998
ASTEION CT SCANNER, TSX-021A
K982787 · JAK
Toshiba America Medical Systems, In.C
Radiology · 72d
Cleared Oct 21, 1998
HOSPAL TIPSTOP
K982818 · KMF
Gambro Healthcare
General & Plastic Surgery · 71d
Cleared Oct 21, 1998
RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE
K982862 · LLZ
Applicare Medical Imaging, B.V.
Radiology · 69d
Cleared Oct 21, 1998
ZETA MULTIZONE SCN LOCKING NAIL
K982873 · HSB
Howmedica Corp.
Orthopedic · 68d
Cleared Oct 21, 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
K982896 · LDD
Alexander Mfg. Co.
Cardiovascular · 65d
Cleared Oct 21, 1998
SULZER ORTHOPEDICS FLUTED STEMS
K982903 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 64d
Cleared Oct 21, 1998
THREADED FIXATION PIN
K982931 · JDW
Sgarlato Laboratories, Inc.
Orthopedic · 62d
Cleared Oct 21, 1998
OSTEONICS EXTENDED FEMORAL BEARING HEAD
K982936 · LWJ
Osteonics Corp.
Orthopedic · 61d
Cleared Oct 21, 1998
TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES
K982953 · HSB
Biomet, Inc.
Orthopedic · 58d
Cleared Oct 21, 1998
ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS
K982984 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 56d
Cleared Oct 21, 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K982987 · MNI
Synthes Spine
Orthopedic · 56d
Cleared Oct 21, 1998
TSRH SPINAL SYSTEM
K982990 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 56d
Cleared Oct 21, 1998
ANSPACH ACCESS CRANIAL PERFORATOR
K982991 · HBF
The Anspach Effort, Inc.
Neurology · 55d
Cleared Oct 21, 1998
GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE
K982998 · JKA
Greiner Meditech, Inc.
Chemistry · 55d
Cleared Oct 21, 1998
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS...
K983053 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 50d
Cleared Oct 21, 1998
CERALAS D LASER SYSTEM, MODEL # CERALAS D15
K983058 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 50d
Cleared Oct 21, 1998
BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR
K983186 · MAI
Linvatec Corp.
Orthopedic · 40d
Cleared Oct 21, 1998
XPS DRILL SYSTEM
K983224 · ERL
Xomed, Inc.
Ear, Nose, Throat · 37d
Cleared Oct 21, 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
K983258 · MNI
Spinal Concepts, Inc.
Orthopedic · 35d
Cleared Oct 21, 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM
K983260 · MNI
Spinal Concepts, Inc.
Orthopedic · 35d
Cleared Oct 21, 1998
ULTRACISION 5MM INSTRUMENTS
K983316 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 30d
Cleared Oct 21, 1998
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
K983416 · JGJ
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Oct 20, 1998
DX-480, ADD ON DIGITAL IMAGER
K981880 · KPR
Wuestec Medical, Inc.
Radiology · 145d