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
93649–93672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1997
INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE
K970423 · MBI
Innovasive Devices, Inc.
Orthopedic · 85d
Cleared Apr 30, 1997
TARGET VITAL-PORT VASCULAR ACCESS SYSTEM
K970442 · LJT
Med Institute, Inc.
General Hospital · 84d
Cleared Apr 30, 1997
IMPLEX BIPOLAR HIP SYSTEM
K970447 · KWY
Implex Corp.
Orthopedic · 83d
Cleared Apr 30, 1997
PCM 2000
K970448 · MSH
Tecnol Medical Products, Inc.
General Hospital · 83d
Cleared Apr 30, 1997
HYFRECATOR 2000
K970493 · GEI
Aspen Labs
General & Plastic Surgery · 79d
Cleared Apr 30, 1997
NATURAL-KNEE II REVISION FEMORAL SPACER LUGS
K970498 · JWH
Intermedics Orthopedics
Orthopedic · 79d
Cleared Apr 30, 1997
3M SUSTEL DENTAL SYSTEM
K970500 · EBF
3M Company
Dental · 79d
Cleared Apr 30, 1997
PEGGED ACETABULAR COMPONENT
K970501 · LPH
Biomet, Inc.
Orthopedic · 79d
Cleared Apr 30, 1997
DEPUY ACE TROCHANTERIC SIDE PLATE
K970503 · HRS
Depuy Ace Medical Co.
Orthopedic · 79d
Cleared Apr 30, 1997
TITANIUM ALLOY BONE SCREWS
K970549 · HWC
Aesculap, Inc.
Orthopedic · 77d
Cleared Apr 30, 1997
BCW POWER ADVANTAGE WHEELCHAIR
K970743 · ITI
Wheelchairs of Kansas
Physical Medicine · 62d
Cleared Apr 30, 1997
IMTEC/TITANIUM MESH
K970841 · JEY
Imtec Corp.
Dental · 54d
Cleared Apr 30, 1997
TARGIS ALLOY #7
K970963 · EJT
Ivoclar North America, Inc.
Dental · 44d
Cleared Apr 29, 1997
MEDRAD DISPOSABLE SYRINGES
K964642 · DXT
Medrad, Inc.
Cardiovascular · 161d
Cleared Apr 29, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
K964695 · DCF
Beckman Instruments, Inc.
Immunology · 158d
Cleared Apr 29, 1997
BK-A
K970204 · DTD
Biotronik, Inc.
Cardiovascular · 98d
Cleared Apr 29, 1997
ALIGNMENT INSTRUMENT
K970345 · HSZ
Richard Wolf Medical Instruments Corp.
Orthopedic · 90d
Cleared Apr 29, 1997
PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
K970418 · GZL
Pmt Corp.
Neurology · 84d
Cleared Apr 29, 1997
BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
K970429 · GZJ
Apex Medical Corp.
Neurology · 84d
Cleared Apr 28, 1997
AS/3 NMT MODULE
K955026 · KOI
Datex Medical Instrumentation, Inc.
Anesthesiology · 543d
Cleared Apr 28, 1997
QUICKIE P300 SERIES
K963381 · ITI
Quickie Designs, Inc.
Physical Medicine · 244d
Cleared Apr 28, 1997
QUICKIE P100 SERIES
K963382 · ITI
Quickie Designs, Inc.
Physical Medicine · 244d
Cleared Apr 28, 1997
QUICKIE POWER WHEELCHAIRS P200 SERIES
K963385 · ITI
Quickie Designs, Inc.
Physical Medicine · 244d
Cleared Apr 28, 1997
MODEL 1920 WASTE GAS SCAVENGER
K963601 · CBN
G. Dundas Co.
Anesthesiology · 231d