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
113617–113640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1993
FPC HIP STEM COMPONENT
K915391 · JDG
Implantology Corp.
Orthopedic · 518d
Cleared Apr 30, 1993
ITC CATHETERS W/ HYDROMER
K922609 · DQY
Interventional Therapeutics Corp.
Cardiovascular · 332d
Cleared Apr 30, 1993
UFC HIP STEM COMPONENT
K924099 · JDG
Implantology Corp.
Orthopedic · 260d
Cleared Apr 30, 1993
710 POROUS HA PARTICLES-BII-PORE
K924287 · LYC
Bio-Interfaces, Inc.
Dental · 248d
Cleared Apr 30, 1993
PMP MUSCLE STIMULATOR
K924699 · IPF
Preferred Medical Products
Physical Medicine · 225d
Cleared Apr 30, 1993
EP AMP, MODEL #901
K925346 · DRR
Quinton Electrophysiology Corp.
Cardiovascular · 190d
Cleared Apr 30, 1993
BLD-18000 SERIES HEATED BREATHING CIRCUIT
K925543 · CAI
Bird Life Design
Anesthesiology · 176d
Cleared Apr 30, 1993
TELEFACTOR D/EEG-32
K925838 · GWQ
Grass-Telefactor Product Group
Neurology · 163d
Cleared Apr 30, 1993
BALANCED(TM) NYLON BLADDER
K930604 · DXQ
Pymah Corp.
Cardiovascular · 84d
Cleared Apr 30, 1993
ENDOSCOPIC RETRACTOR
K931092 · GCJ
L.A.S.E.R., Inc.
General & Plastic Surgery · 58d
Cleared Apr 29, 1993
STABILITY HIP STEM WITH POROCOAT
K915787 · JDG
Depuy, Inc.
Orthopedic · 492d
Cleared Apr 29, 1993
CARDIFIX ENDOCARDIAL PACING LEAD
K922042 · DTB
Intermedics, Inc.
Cardiovascular · 363d
Cleared Apr 29, 1993
NEEDLE-PRO CARTRIDGE
K923127 · FMI
Concord/Portex
General Hospital · 307d
Cleared Apr 29, 1993
FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W
K924669 · FPP
Ferno
General Hospital · 225d
Cleared Apr 29, 1993
ISI SELF-SUPPORTING ARM
K925005 · BWN
Instrumentation Specialties, Inc.
General & Plastic Surgery · 209d
Cleared Apr 29, 1993
REPLACEMENT RECHARGEABLE BATTERY PACK'S
K925449 · FRN
Portable Power Systems, Inc.
General Hospital · 183d
Cleared Apr 29, 1993
GUIDE WIRE FOR LAPOROSCOPIC USE
K926214 · GCJ
Terumo Medical Corp.
General & Plastic Surgery · 140d
Cleared Apr 29, 1993
ASI CYSTOLASE LASER CYSTOSCOPE
K930361 · GEX
Advanced Surgical Intervention, Inc.
General & Plastic Surgery · 93d
Cleared Apr 29, 1993
AMPLATZ GUIDEWIRES
K930622 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 80d
Cleared Apr 29, 1993
AUTO SUTURE DILATING CANNULA
K931337 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 44d
Cleared Apr 27, 1993
FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK
K921112 · KPR
Fujifilm Medical System U.S.A., Inc.
Radiology · 414d
Cleared Apr 27, 1993
SONICATOR PLUS
K921436 · IMG
Mettler Electronics Corp.
Physical Medicine · 398d
Cleared Apr 27, 1993
SYSTEM 97
K922235 · DSP
Datascope Corp.
Cardiovascular · 349d
Cleared Apr 27, 1993
THE ACTA FORMULA
K922703 · DPS
Biosound, Inc.
Cardiovascular · 326d