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
131785–131808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVES (STERILE & NON-STERILE)
K890857 · LYY
Health & Hospital Intl.
General Hospital · 30d
Cleared Mar 23, 1989
ATS DOBELL & O'CONNOR'S IODINE
K890861 · JTS
Alpha-Tec Systems, Inc.
Pathology · 30d
Cleared Mar 23, 1989
TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS
K890881 · GWQ
Teca, Inc.
Neurology · 30d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVE, VINYL
K891067 · LYZ
Sun Flower Gloves Co., Ltd.
General Hospital · 22d
Cleared Mar 23, 1989
GRAND COOLING MACHINE
K891152 · ILO
Kinetic Concepts, Inc.
Physical Medicine · 20d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891170 · LYY
Ching Pax Trading Co., Ltd.
General Hospital · 17d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891181 · LYY
Behn Meyer & Co. (M) Sdn Bhd
General Hospital · 17d
Cleared Mar 23, 1989
LATEX EXAMINATION GLOVES
K891206 · LYY
Charug Fang Ent.
General Hospital · 17d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891443 · LYY
Sukas Sdn Bhd
General Hospital · 8d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891446 · LYY
Felda Rubber Corp.
General Hospital · 8d
Cleared Mar 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891447 · LYY
Lily Corp.
General Hospital · 8d
Cleared Mar 22, 1989
FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)
K884631 · LRC
Xomed, Inc.
Ear, Nose, Throat · 135d
Cleared Mar 22, 1989
LILY I.V. SET
K884657 · FPA
Modec Co., Inc.
General Hospital · 135d
Cleared Mar 22, 1989
TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1
K884866 · LDF
Oscor Medical Corp.
Cardiovascular · 121d
Cleared Mar 22, 1989
SIMRITE VERIFICATION AND SIMULATION SYSTEM
K885081 · KPQ
Haynes Radiation Ltd., Inc.
Radiology · 103d
Cleared Mar 22, 1989
MULTIPLE (STERILE SURGICAL TOWELS)
K885099 · KKX
Med-Tex, Inc.
General Hospital · 100d
Cleared Mar 22, 1989
ASPIRATING AND IRRIGATING CYSTS NEEDLES
K885283 · GDM
Go Medical Industries Pty. , Ltd.
General & Plastic Surgery · 92d
Cleared Mar 22, 1989
COBAS MFC
K885292 · JQP
Roche Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Mar 22, 1989
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K885321 · FRO
Pfizer Pharmaceuticals
General & Plastic Surgery · 84d
Cleared Mar 22, 1989
RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER
K885328 · GYE
Telediagnostic Systems, Inc.
Neurology · 84d
Cleared Mar 22, 1989
SURGIMAX (LATEX EXAM GLOVES)
K890149 · LYY
National Dental Supply, Inc.
General Hospital · 68d
Cleared Mar 22, 1989
MICROTRAK CHLAMYDIA EIA
K890196 · LJC
Syva Co.
Microbiology · 63d
Cleared Mar 22, 1989
SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS
K890547 · DTB
Pacesetter Systems
Cardiovascular · 47d
Cleared Mar 22, 1989
SATLITE TRANS PORTABLE PULSE OXIMETER
K890753 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 37d