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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
131377–131400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1989
BELZER UW-CSS
K883782 · KDL
Du Pont Critical Care
Gastroenterology & Urology · 226d
Cleared Apr 20, 1989
SURGICAL 'LASER' DRAPE
K884231 · KKX
Henley Intl.
General Hospital · 195d
Cleared Apr 20, 1989
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200
K884598 · JAA
Shimadzu Precision Instruments, Inc.
Radiology · 168d
Cleared Apr 20, 1989
ARISTA AND ORIENT SURGICAL GLOVES
K884633 · KGO
Durante Intl., Inc.
General Hospital · 164d
Cleared Apr 20, 1989
MEDILOG 6000-FD REPORT GENERATOR
K890330 · DSI
Oxford Medilog, Inc.
Cardiovascular · 87d
Cleared Apr 20, 1989
JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES
K890459 · KGO
James River Corp.
General Hospital · 80d
Cleared Apr 20, 1989
OHMEDA 5330 AGENT MONITOR
K890606 · CBQ
Ohmeda Medical
Anesthesiology · 73d
Cleared Apr 20, 1989
RESPIRONICS SEALEASY II
K890795 · BSJ
Respironics, Inc.
Anesthesiology · 62d
Cleared Apr 20, 1989
SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
K891293 · KPQ
Philips Medical Systems North...
Radiology · 41d
Cleared Apr 20, 1989
STERILE SURGEONS' GLOVES
K891621 · KGO
Albors-Menconi Latex Corp.
General Hospital · 34d
Cleared Apr 20, 1989
COATED ISOLATION GOWN
K891677 · FYC
Durante Intl., Inc.
General Hospital · 30d
Cleared Apr 20, 1989
NON-STERILE MASKS AND CAPS
K892118 · FYA
Paramount Products, Inc.
General Hospital · 21d
Cleared Apr 19, 1989
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
K883969 · HRY
Intermedics Orthopedics
Orthopedic · 211d
Cleared Apr 19, 1989
EXCEL Y-CONNECTOR CAT. #E-201
K884327 · LIT
Medical Profiles, Inc.
Cardiovascular · 187d
Cleared Apr 19, 1989
HEPARIN BONDING FOR CATHETERS
K884697 · DTB
Daig Corp.
Cardiovascular · 161d
Cleared Apr 19, 1989
VITAL SIGNS MONITOR
K884938 · DSK
Tico Medical Instruments, Inc.
Cardiovascular · 142d
Cleared Apr 19, 1989
POROUS COATED GENESIS FEMORAL COMPONENT
K885036 · JWH
Richards Medical Co., Inc.
Orthopedic · 135d
Cleared Apr 19, 1989
SYSTEM SEVENTY SEVEN
K885054 · IYX
Scinticor, Inc.
Radiology · 133d
Cleared Apr 19, 1989
OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT
K885201 · ETA
Microbio-Medics, Inc.
Ear, Nose, Throat · 124d
Cleared Apr 19, 1989
HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)
K885204 · DSI
Mennen Medical, Inc.
Cardiovascular · 121d
Cleared Apr 19, 1989
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Apr 19, 1989
PROSTHETIC CEMENT REMOVER
K890285 · LZV
Albert K. Chin
Orthopedic · 90d
Cleared Apr 19, 1989
MEDILOG EDITOR
K890338 · DSI
Oxford Medilog, Inc.
Cardiovascular · 86d
Cleared Apr 19, 1989
NEOTECH MUCUS TRAP W/CATHETER
K890425 · BSY
Neotech Products, Inc.
Anesthesiology · 83d