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
109945–109968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1994
HYPERINFLATION BAG SYSTEM
K940255 · NHK
Nutec, Inc.
Anesthesiology · 29d
Cleared Feb 17, 1994
STERILE TROCAR AND 5.7MM SLEEVE
K940259 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 27d
Cleared Feb 17, 1994
RECORD
K940303 · IOR
Everest & Jennings, Inc.
Physical Medicine · 24d
Cleared Feb 17, 1994
NITRO
K940304 · IOR
Everest & Jennings, Inc.
Physical Medicine · 24d
Cleared Feb 16, 1994
PARALLELING GUIDES
K914715 · FZX
Implant Corp. of America
General & Plastic Surgery · 852d
Cleared Feb 16, 1994
MALLORY-HEAD TOTAL HIP SYSTEM
K921181 · LZO
Biomet, Inc.
Orthopedic · 708d
Cleared Feb 16, 1994
BIMETRIC TOTAL HIP SYSTEM
K921224 · LZO
Biomet, Inc.
Orthopedic · 705d
Cleared Feb 16, 1994
INTEGRAL TOTAL HIP SYSTEM
K921225 · LZO
Biomet, Inc.
Orthopedic · 705d
Cleared Feb 16, 1994
RANAWAT/BURSTEIN TOTAL HIP SYSTEM
K921277 · LPH
Biomet, Inc.
Orthopedic · 701d
Cleared Feb 16, 1994
TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM
K921301 · LPH
Biomet, Inc.
Orthopedic · 700d
Cleared Feb 16, 1994
PMI HIP FEMORAL
K923452 · LPH
Biomet, Inc.
Orthopedic · 582d
Cleared Feb 16, 1994
MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE
K924380 · MLR
Mdt Corp., Inc.
General Hospital · 534d
Cleared Feb 16, 1994
SAFESNAP SAFETY SYRINGE
K925039 · MEG
U.S. Medical Instruments, Inc.
General Hospital · 499d
Cleared Feb 16, 1994
MODIFIED SITE TXR SYSTEMS
K925828 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 457d
Cleared Feb 16, 1994
ASPIRATING ENDO OCULAR PROBE
K930123 · EQH
Surgical Technologies, Inc.
Ear, Nose, Throat · 400d
Cleared Feb 16, 1994
OPHTHALMIC FRAMES W/DEMO LENSES & CLIP ON SUNGLASS
K930566 · HQZ
E.B. Brown Opticians
Ophthalmic · 378d
Cleared Feb 16, 1994
SUNGLASSES
K930659 · HQY
Kai Tai Optical Mfg. Co. , Ltd.
Ophthalmic · 372d
Cleared Feb 16, 1994
16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
K931338 · HGI
Aaron Medical Industries
Obstetrics & Gynecology · 337d
Cleared Feb 16, 1994
FUJINON VIDEO LAPAROSCOPE -- MODIFIED
K932312 · FET
Fujinon, Inc.
Gastroenterology & Urology · 281d
Cleared Feb 16, 1994
ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT
K932858 · JWH
Dow Corning Wright
Orthopedic · 251d
Cleared Feb 16, 1994
INSTRUMENT DETERGENT CONCENTRATE
K933149 · FLG
Nobelpharma USA, Inc.
General Hospital · 232d
Cleared Feb 16, 1994
MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH...
K934320 · HQR
Mentor O & O, Inc.
Ophthalmic · 166d
Cleared Feb 16, 1994
2C LENS FOG REDUCTION & CLEANING DEVICE
K934528 · GCJ
H & C Chemical, Inc.
General & Plastic Surgery · 152d
Cleared Feb 16, 1994
CLAVE VIAL ACCESS SPIKE
K934591 · FMI
Icu Medical, Inc.
General Hospital · 145d