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
96337–96360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1996
FLEX NEEDLE
K961049 · FPA
Lighthouse Medical, Inc.
General Hospital · 187d
Cleared Sep 18, 1996
FLEXSCOPE
K961536 · GDB
Matrix Medica, Inc.
Gastroenterology & Urology · 149d
Cleared Sep 18, 1996
RYDER LACRIMAL INTUBATIONSET
K962151 · OKS
Ryder Intl. Corp.
Ophthalmic · 106d
Cleared Sep 18, 1996
SAFETY VEST
K962429 · FMQ
Johnson & Johnson Professionals, Inc.
General Hospital · 86d
Cleared Sep 18, 1996
PROSPORE(STEARO FOR STEAM STERILIZER)
K962441 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 86d
Cleared Sep 18, 1996
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K962843 · JSM
Starplex Scientific, Inc.
Microbiology · 58d
Cleared Sep 18, 1996
ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY)
K963157 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 55d
Cleared Sep 17, 1996
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
K952220 · LYR
Meretek Diagnostics, Inc.
Microbiology · 495d
Cleared Sep 17, 1996
BRAUN HEMODIALYSIS CATHETER
K952660 · MPB
B.Braun Medical, Inc.
Gastroenterology & Urology · 463d
Cleared Sep 17, 1996
OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS
K960647 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 215d
Cleared Sep 17, 1996
THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR
K960851 · BZQ
Pro-Tech Services, Inc.
Anesthesiology · 200d
Cleared Sep 17, 1996
LATEX PATIENT EXAMINATION GLOVE
K960942 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 217d
Cleared Sep 17, 1996
SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR...
K960984 · JDI
Biomet, Inc.
Orthopedic · 190d
Cleared Sep 17, 1996
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K961186 · LPH
Depuy, Inc.
Orthopedic · 175d
Cleared Sep 17, 1996
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · FYA
Depuy, Inc.
General Hospital · 169d
Cleared Sep 17, 1996
DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
K961345 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 162d
Cleared Sep 17, 1996
PRESS-FIT POROUS SHELL
K961526 · LPH
Encore Orthopedics, Inc.
Orthopedic · 148d
Cleared Sep 17, 1996
VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K961572 · MNH
Wrightmedicaltechnologyinc
Orthopedic · 147d
Cleared Sep 17, 1996
BRAUN PERCUTANEOUS INTRODUCER SET
K961745 · DYB
B.Braun Medical, Inc.
Cardiovascular · 134d
Cleared Sep 17, 1996
CROSS PIN
K961920 · JDW
Medicinelodge, Inc.
Orthopedic · 123d
Cleared Sep 17, 1996
RHYDER DIAGNOSTIC CATHETER
K962307 · DRF
Fidus Medical Technology Corp.
Cardiovascular · 92d
Cleared Sep 17, 1996
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
K962393 · GCM
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 89d
Cleared Sep 17, 1996
RV PACING LEAD
K962467 · LDF
Abbott Laboratories
Cardiovascular · 84d
Cleared Sep 17, 1996
REFLECTION ACETABULAR REINFORCEMENT RINGS
K962541 · JDJ
Smith & Nephew Richards, Inc.
Orthopedic · 81d