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
120025–120048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1991
ESCORT 300 SERIES
K911665 · LDD
Medical Data Electronics
Cardiovascular · 139d
Cleared Aug 29, 1991
EYE TRAY
K912105 · LRP
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 108d
Cleared Aug 29, 1991
ARTHROSCOPY TRAY
K912106 · FSM
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 108d
Cleared Aug 29, 1991
MAJOR SET-UP TRAY
K912159 · GCJ
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 105d
Cleared Aug 29, 1991
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
K912190 · JDZ
Stryker Corp.
Orthopedic · 104d
Cleared Aug 29, 1991
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC
K912263 · MEH
Zimmer, Inc.
Orthopedic · 99d
Cleared Aug 29, 1991
SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER
K912792 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 65d
Cleared Aug 29, 1991
API UNISCEPT MIC/UNISCEPT MICRO-MIC
K912964 · JWY
Analytab Products, Inc.
Microbiology · 52d
Cleared Aug 29, 1991
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN
K913229 · LLH
Baxter Diagnostics, Inc.
Microbiology · 38d
Cleared Aug 29, 1991
GLOBALCARE ELECTRODE
K913373 · GXY
Globalcare Intl., Inc.
Neurology · 31d
Cleared Aug 29, 1991
IMPALA
K913512 · IOR
Pin Dot Products, Inc.
Physical Medicine · 22d
Cleared Aug 29, 1991
DUKKI
K913544 · INM
Pin Dot Products, Inc.
Physical Medicine · 20d
Cleared Aug 29, 1991
PIN DOT FOOTREST PRODUCTS
K913552 · KNN
Pin Dot Products, Inc.
Physical Medicine · 20d
Cleared Aug 28, 1991
MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR
K897068 · DTZ
Medtronic Vascular
Cardiovascular · 615d
Cleared Aug 28, 1991
THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER
K901281 · DRB
Val-Mark Medical, Inc.
Cardiovascular · 527d
Cleared Aug 28, 1991
DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535
K905198 · IYN
Bruel & Kjaer
Radiology · 281d
Cleared Aug 28, 1991
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP
K910609 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 197d
Cleared Aug 28, 1991
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
K910924 · DTB
Pacesetter Systems
Cardiovascular · 176d
Cleared Aug 28, 1991
JMS AV FISTULA NEEDLES
K911199 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Aug 28, 1991
100 CM PERMANENT PACING LEAD MODELS
K911273 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 159d
Cleared Aug 28, 1991
ENDOSTAPLE
K911829 · GCI
Ethicon, Inc.
General & Plastic Surgery · 126d
Cleared Aug 28, 1991
POLAROID HELIOS LASER IMAGER
K912073 · LMC
Polaroid Medical Corp.
Radiology · 110d
Cleared Aug 28, 1991
BONE MARROW BIOPSY TRAY
K912074 · GAA
Manan Medical Products, Inc.
General & Plastic Surgery · 110d
Cleared Aug 28, 1991
THE SPRITZ BATH
K912179 · KTC
The Spritz Co.
Physical Medicine · 104d