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
97105–97128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1996
DUREX, RAMSES, SHEIK
K952415 · LTZ
London International U.S. Holdings, Inc.
Obstetrics & Gynecology · 419d
Cleared Jul 15, 1996
3M RED DOT ECG LEAD WIRES A
K954900 · DSA
Minnesota Mining and Mfg. Co.
Cardiovascular · 264d
Cleared Jul 15, 1996
CARDIMAX MODEL FX-2111
K955416 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 231d
Cleared Jul 15, 1996
MARPP PRESSURE MONITORING SYSTEM
K960725 · KYZ
Paradigm Medical, Inc.
General Hospital · 144d
Cleared Jul 15, 1996
MBI FIBEROPTIC ENDO-ILLUMINATOR
K961036 · MPA
M.B. Industries, Inc.
Ophthalmic · 123d
Cleared Jul 15, 1996
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
K961077 · BWF
Healthscan Products, Inc.
Anesthesiology · 119d
Cleared Jul 15, 1996
STRYKER CEMENT REMOVAL SYSTEM
K961101 · LZV
Stryker Corp.
Orthopedic · 118d
Cleared Jul 15, 1996
MAXIM PF MODELS 033-581/033-590
K961118 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 117d
Cleared Jul 15, 1996
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
K961316 · MGQ
Renaissance Pharmaceutical, Inc.
General & Plastic Surgery · 101d
Cleared Jul 15, 1996
R&D RETIC-PG HEMATOLOGY CONTROL
K961673 · JPK
R&D Systems, Inc.
Hematology · 75d
Cleared Jul 15, 1996
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)
K961747 · HRX
Arthrocare Corp.
Orthopedic · 70d
Cleared Jul 15, 1996
WOUND HYDROGEL & STERILE WOUND HYDROGEL
K961766 · MGQ
Renaissance Pharmaceutical, Inc.
General & Plastic Surgery · 73d
Cleared Jul 15, 1996
NATURAL HIP SYSTEM - DRG HIP STEM
K961799 · JDI
Intermedics Orthopedics
Orthopedic · 67d
Cleared Jul 15, 1996
NEEDLE CATHETER
K961846 · FBK
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Jul 15, 1996
SANPOINT MENSTRUAL TAMPON
K961926 · HEB
Sanpoint AB
Obstetrics & Gynecology · 59d
Cleared Jul 15, 1996
BURLEW INFANT HOOD
K962182 · FOG
Promedic, Inc.
Anesthesiology · 39d
Cleared Jul 15, 1996
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
K962384 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 25d
Cleared Jul 15, 1996
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
K962413 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 24d
Cleared Jul 12, 1996
HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
K954559 · HSD
Howmedica Corp.
Orthopedic · 284d
Cleared Jul 12, 1996
EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS
K960048 · FXX
Safetec of America, Inc.
General Hospital · 190d
Cleared Jul 12, 1996
EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP
K960073 · FYA
Safetec of America, Inc.
General Hospital · 189d
Cleared Jul 12, 1996
NATURAL HIP SYSTEM
K960258 · JDI
Intermedics Orthopedics
Orthopedic · 176d
Cleared Jul 12, 1996
HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
K960669 · CFF
Morax
Immunology · 143d
Cleared Jul 12, 1996
RX TEXTILES STERILE STOCKINETTE
K960803 · KKX
Rx Textiles, Inc.
General Hospital · 136d