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
102385–102408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 1995
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K944979 · LNH
GE Medical Systems
Radiology · 245d
Cleared Jun 13, 1995
FLEXILOG 2000
K945069 · FFT
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 242d
Cleared Jun 13, 1995
VALLEYLAB PROCISION(TM) SYSTEM
K945688 · GEI
Valleylab, Inc.
General & Plastic Surgery · 204d
Cleared Jun 13, 1995
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC...
K945787 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 200d
Cleared Jun 13, 1995
EAR-A-GATOR
K946108 · KHH
Life-Tech Intl., Inc.
Ear, Nose, Throat · 181d
Cleared Jun 13, 1995
MODEL 3200P/3200PR HYPERBARIC CHAMBER
K950386 · CBF
Sechrist Industries, Inc.
Anesthesiology · 132d
Cleared Jun 13, 1995
VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM
K951076 · LJT
Med Institute, Inc.
General Hospital · 96d
Cleared Jun 13, 1995
NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM
K951119 · GCX
American Hydro-Surgical Instruments,...
General Hospital · 95d
Cleared Jun 13, 1995
SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0
K951189 · JJE
Beckman Instruments, Inc.
Chemistry · 89d
Cleared Jun 13, 1995
GENERAL AND PLASTIC SURGERY PACKS
K951478 · LRO
Sterile Concepts, Inc.
General & Plastic Surgery · 75d
Cleared Jun 13, 1995
LASEVAC
K951490 · HET
D.D. Surgical, Inc.
Obstetrics & Gynecology · 74d
Cleared Jun 13, 1995
ENTEROCOCCUS SCREENING MEDIUM
K951539 · JWY
Becton Dickinson Microbiology Systems
Microbiology · 71d
Cleared Jun 13, 1995
CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY
K951796 · JLW
Ciba Corning Diagnostics Corp.
Chemistry · 55d
Cleared Jun 13, 1995
RUSCH INTERNATIONAL URODYNAMIC CATHETERS
K952029 · FEN
Rusch Intl.
Gastroenterology & Urology · 43d
Cleared Jun 13, 1995
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM
K952075 · JLS
Bayer Corp.
Chemistry · 41d
Cleared Jun 12, 1995
SUTTER HAMMERTOE JOINT PROSTHESIS
K943354 · KWH
Sutter Corp.
Orthopedic · 335d
Cleared Jun 12, 1995
ACUFEX PATELLAR BONE BLOCK SIZER
K944500 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 271d
Cleared Jun 12, 1995
LUHR TITANIUM ALLOY PAN FIXATION SYSTEM
K945137 · HRS
Howmedica Corp.
Orthopedic · 235d
Cleared Jun 12, 1995
LUHR TITANIUM PAN FIXATION SYSTEM
K945139 · HRS
Howmedica Corp.
Orthopedic · 235d
Cleared Jun 12, 1995
THE LOTECON PERSONAL CARE SYSTEM
K950191 · FNM
Lotecon, Inc.
General Hospital · 146d
Cleared Jun 12, 1995
CIRCULON SYSTEM STEP 2
K951021 · MCY
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 97d
Cleared Jun 12, 1995
CIRCULON SYSTEM STEP 1
K951022 · MCY
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 97d
Cleared Jun 12, 1995
SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEM
K951165 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 90d
Cleared Jun 12, 1995
DEGULOR A
K951786 · EJT
Degussa Corp.
Dental · 56d