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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
153865–153888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1984
IV ADMINISTRATION SET
K840081 · FPA
Lee Medical Intl., Inc.
General Hospital · 42d
Cleared Feb 21, 1984
STERILE INSULIN DISPOS. NEEDLE/SYRINGE
K840082 · FMF
Lee Medical Intl., Inc.
General Hospital · 42d
Cleared Feb 21, 1984
STERILE INSULIN DISPOS. NEEDLE/GREEN
K840083 · FMF
Lee Medical Intl., Inc.
General Hospital · 42d
Cleared Feb 21, 1984
COUNTER MODEL S880
K840128
Coulter Electronics, Inc.
Hematology · 41d
Cleared Feb 21, 1984
COMPUTED TOMOGRAPHY CALIBRATION PHANT
K840131 · IXG
Imatron, Inc.
Radiology · 42d
Cleared Feb 21, 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K840224 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 33d
Cleared Feb 21, 1984
CAL-CHEX, A HEMATOLOGY CALIBRATOR
K840261 · KRZ
Streck Laboratories, Inc.
Hematology · 47d
Cleared Feb 21, 1984
POST-AURICULAR HEARING AID
K840359 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 26d
Cleared Feb 21, 1984
SEP PROGRAMMER SEP-M/SINGLE-PLANE &
K840389 · IZP
Elema-Schonander, Inc.
Radiology · 22d
Cleared Feb 21, 1984
TECHNICARE MODEL 1047
K840390 · JAA
Technicare Corp.
Radiology · 22d
Cleared Feb 21, 1984
HEMASITE/RENALOY -VASCULAR ACCESS SHUNT
K840436 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 20d
Cleared Feb 21, 1984
HEMASITE ACCESSORIES MODIFICATION
K840437 · KNZ
Renal Systems, Inc.
Gastroenterology & Urology · 20d
Cleared Feb 21, 1984
DIGITAL CRADLE
K840463 · KXH
Spectrum X-Ray Corp.
Radiology · 19d
Cleared Feb 21, 1984
MALE INSERT SLIP
K840482 · EYQ
Beghin_Say Intl., Inc.
Gastroenterology & Urology · 15d
Cleared Feb 21, 1984
SEDIPLAST
K840500 · JPH
Precision Technology, Inc.
Hematology · 15d
Cleared Feb 21, 1984
DISPOS. ANESTHESIA FACE MASK
K840535 · BSJ
Marquest Medical Products, Inc.
Anesthesiology · 13d
Cleared Feb 17, 1984
MEMORY LOOP TRANSMITTER #121
K832951 · DXH
Biometric Products, Inc.
Cardiovascular · 168d
Cleared Feb 17, 1984
FLORET FOAM PREP SPONGE
K833626 · GDY
Ritmed, Inc.
General & Plastic Surgery · 126d
Cleared Feb 17, 1984
SIGMA 20 ELECTRONIC SECTOR SCANNER
K833680 · IYO
Kontron Instruments, Inc.
Radiology · 119d
Cleared Feb 17, 1984
QUICK-COUNT HEMATOLOGY REAGENT KIT
K833972 · GIF
Seragen Diagnostics, Inc.
Hematology · 93d
Cleared Feb 17, 1984
PMT-HALO/ORTHOPEDIC JACKET SYSTEM
K834047 · HAX
Progress Mankind Technology
Neurology · 86d
Cleared Feb 17, 1984
INSTRUMENT TIP PROTECTION COVERS
K834127 · LXZ
Devon Industries, Inc.
General & Plastic Surgery · 80d
Cleared Feb 17, 1984
MOD 456
K834276 · IYO
Hoffrel Instruments, Inc.
Radiology · 109d
Cleared Feb 17, 1984
MOD 427
K834277 · IYO
Hoffrel Instruments, Inc.
Radiology · 109d