FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131617–131640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892511 · LYY
Ampac Rubber Co., Ltd.
General Hospital · 30d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892512 · LYY
Sar King Ent. Co., Ltd.
General Hospital · 30d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892677 · LYY
Ultrajaya Sdn. Bhd.
General Hospital · 31d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892679 · LYY
Mastervest Corp. Sdn Bhd.
General Hospital · 31d
Cleared May 11, 1989
L3 (LEAD LATEX LYSNIG GLOVES)
K882437 · LZC
The Branford Co.
General Hospital · 331d
Cleared May 11, 1989
EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550
K883600 · LLM
Clinical Sciences, Inc.
Microbiology · 261d
Cleared May 11, 1989
EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550
K883601 · LLM
Clinical Sciences, Inc.
Microbiology · 261d
Cleared May 11, 1989
PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM
K885327 · LMB
Philips Medical Systems North...
Radiology · 134d
Cleared May 11, 1989
TYPE 9225 NIBP
K890005 · DXN
S & W Medico Teknik
Cardiovascular · 128d
Cleared May 11, 1989
PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000
K890084 · FTC
Psoralite Corp.
General & Plastic Surgery · 121d
Cleared May 11, 1989
ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4
K890102 · ESD
Hear Clear, Inc.
Ear, Nose, Throat · 119d
Cleared May 11, 1989
FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM
K890329 · FIL
Fresenius USA, Inc.
Gastroenterology & Urology · 108d
Cleared May 11, 1989
FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM
K890824 · FKP
Fresenius USA, Inc.
Gastroenterology & Urology · 83d
Cleared May 11, 1989
CERVEX-BRUSH
K890848 · HHT
Unimar, Inc.
Obstetrics & Gynecology · 79d
Cleared May 11, 1989
TRUVEL TZ-3X X-RAY DIGITIZING SCANNER
K890970 · LMA
Truvel Corp.
Radiology · 73d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVE
K890975 · LYY
Kleartex Sdn Bhd
General Hospital · 73d
Cleared May 11, 1989
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
K891005 · FPK
3M Company
General Hospital · 72d
Cleared May 11, 1989
MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM
K891148 · DSI
Del Mar Avionics
Cardiovascular · 69d
Cleared May 11, 1989
NEWPORT LATERAL VAGINAL RETRACTOR
K891351 · KOH
Simpson/Basye, Inc.
Obstetrics & Gynecology · 62d
Cleared May 11, 1989
RETRACTOR RODS
K891398 · KNA
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 58d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX) (POWDERED)
K891428 · LYY
Bio-Aid Industries Sdn Bhd
General Hospital · 58d
Cleared May 11, 1989
OBSTETRIC CUP (MODIFICATION)
K891465 · HDB
Go Medical Industries Pty. , Ltd.
Obstetrics & Gynecology · 57d
Cleared May 11, 1989
FIRST AID SURVIVAL KIT
K891483 · LRR
Elwyn, Inc.
General & Plastic Surgery · 55d
Cleared May 11, 1989
MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.
K891541 · LNH
Diasonics, Inc.
Radiology · 55d