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
126457–126480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1990
DOMED AND FINNED ACETABULAR COMPONENT
K901328 · JDI
Orthomet, Inc.
Orthopedic · 62d
Cleared May 22, 1990
KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM
K901338 · JWH
Kirschner Medical Corp.
Orthopedic · 61d
Cleared May 22, 1990
USCI(R) ACCESS(TM) INTRODUCER SET
K901452 · DYB
C.R. Bard, Inc.
Cardiovascular · 55d
Cleared May 22, 1990
LSF(TM) TOTAL HIP SYSTEM
K901460 · JDI
Implant Technology, Inc.
Orthopedic · 55d
Cleared May 22, 1990
DNP 60-B UNIPOLAR ENDOCARDIAL LEAD
K901709 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 39d
Cleared May 22, 1990
KLEIN MICRO-CANNULA HANDLE(TM)
K901719 · GEA
Jeff Klein Surgical, Inc.
General & Plastic Surgery · 39d
Cleared May 22, 1990
HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
K901774 · DQA
Mennen Medical, Inc.
Anesthesiology · 33d
Cleared May 21, 1990
PATIENT EXAM GLOVES (MFG. KOON SENG)
K893071 · LYY
Innovative Medical Suppliers
General Hospital · 403d
Cleared May 21, 1990
SIEMENS MODEL 284 PP-L
K893573 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 284 PP-AGC
K893574 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 283 ASP
K893575 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
SIEMENS MODEL 284 PP
K893576 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 377d
Cleared May 21, 1990
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K900908 · HIG
Zimmer, Inc.
Obstetrics & Gynecology · 83d
Cleared May 21, 1990
OMNIPATCH
K900941 · HOY
Eye Garter Company, Inc.
Ophthalmic · 82d
Cleared May 21, 1990
CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST
K901243 · LJP
Cel Labs Pty, Ltd.
Microbiology · 67d
Cleared May 21, 1990
THE TONGUE BRUSH
K901408 · LCN
Garry Laboratories, Inc.
Dental · 56d
Cleared May 21, 1990
PATHO DX STREP D
K902038 · GTZ
Diagnostic Products Corp.
Immunology · 17d
Cleared May 18, 1990
CAV SAT OXIMETER MODEL 100
K892217 · DQA
Somanetics Corp.
Anesthesiology · 410d
Cleared May 18, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892305 · LYY
Hemipan Trading & Mfg. Co. (P) , Ltd.
General Hospital · 407d
Cleared May 18, 1990
PATIENT EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)
K893072 · LYZ
Innovative Medical Suppliers
General Hospital · 400d
Cleared May 18, 1990
FRANK INHALER THERMAL S
K895115 · CCQ
Buttner-Frank GmbH
Anesthesiology · 276d
Cleared May 18, 1990
DESERET MULTILUMEN SUBCLAVIAN CATHETER
K895735 · LYY
Deseret Medical, Inc.
General Hospital · 233d
Cleared May 18, 1990
SECHRIST VOLUME VENTILATOR MODEL 2200B
K896269 · CBK
Sechrist Industries, Inc.
Anesthesiology · 199d
Cleared May 18, 1990
LATEX PATIENT EXAMINATION GLOVES
K900119 · LYY
Cen Tex Industrial Co., Ltd.
General Hospital · 129d