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
114337–114360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1993
ACUCISE URETERAL CUTTING CATHETER
K921838 · EYB
Applied Urology, Inc.
Gastroenterology & Urology · 315d
Cleared Feb 26, 1993
KB58-KF
K922958 · EJS
Jeneric/Pentron, Inc.
Dental · 253d
Cleared Feb 26, 1993
AT-2
K923007 · EWO
Qualitone
Ear, Nose, Throat · 249d
Cleared Feb 26, 1993
MICROSTAR
K923713 · EJT
J.F. Jelenko & Co., Inc.
Dental · 214d
Cleared Feb 26, 1993
PRESSURE GAUGE
K923800 · BSK
Innovations For Mechanical...
Anesthesiology · 212d
Cleared Feb 26, 1993
OMEGASCOPE
K924228 · FBN
Omega Universal Technologies, Ltd.
Gastroenterology & Urology · 189d
Cleared Feb 26, 1993
DSP SCREENING AUDIOMETER
K924543 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 171d
Cleared Feb 26, 1993
MODIFIED ARTICULATING ENDOSCOPIC CLAMP
K925150 · GEI
United States Medical Corp.
General & Plastic Surgery · 136d
Cleared Feb 26, 1993
KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE
K925721 · LMA
Eastman Kodak Company
Radiology · 106d
Cleared Feb 26, 1993
CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR
K925725 · IZH
Bennett X-Ray Corp.
Radiology · 105d
Cleared Feb 26, 1993
TELESHARE 910
K925793 · LLZ
Dejarnette Research Systems
Radiology · 102d
Cleared Feb 26, 1993
KENDALL WOUND DRAINAGE SYSTEMS-TROCARS
K925805 · GBX
Kendall Healthcare Products Co....
General & Plastic Surgery · 102d
Cleared Feb 26, 1993
KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR
K925989 · GCY
Kendall Healthcare Products Co....
General & Plastic Surgery · 93d
Cleared Feb 25, 1993
UROTECH CATHETER
K911617 · EZL
Urotech U.S.A., Inc.
Gastroenterology & Urology · 686d
Cleared Feb 25, 1993
SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
K913177 · CAC
Solco Basle, Inc.
Anesthesiology · 589d
Cleared Feb 25, 1993
SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
K913247 · CAC
Solco Basle, Inc.
Anesthesiology · 584d
Cleared Feb 25, 1993
FRESENIUS VARIABLE FILL MONITOR
K921052 · KDJ
Fresenius USA, Inc.
Gastroenterology & Urology · 357d
Cleared Feb 25, 1993
DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101
K922009 · DSA
Remington Medical, Inc.
Cardiovascular · 302d
Cleared Feb 25, 1993
CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM
K922887 · GGN
Precision Biologicals, Inc.
Hematology · 254d
Cleared Feb 25, 1993
WITT BIOMEDICAL SERIES II-EP
K923054 · MHX
Witt Biomedical Corporation
Cardiovascular · 246d
Cleared Feb 25, 1993
VIDAS TOXOPLASMA GONDII IGM ASSSAY
K923166 · LGD
Biomerieux Vitek, Inc.
Microbiology · 241d
Cleared Feb 25, 1993
CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE
K924554 · LYK
Clarus Medical Systems, Inc.
Cardiovascular · 169d
Cleared Feb 25, 1993
CATHETER INTRODUCER
K924562 · DYB
Luther Medical Products, Inc.
Cardiovascular · 169d
Cleared Feb 25, 1993
HMP 4000 INTERFERENTIAL STIMULATOR
K924961 · LIH
Hmp 4000, Inc.
Neurology · 148d