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
138409–138432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1987
RAPID ELECTROPHORESIS SYSTEM (REP)
K873352 · JJN
Helena Laboratories
Chemistry · 19d
Cleared Sep 08, 1987
GAMMA GLUTAMYLTRANSFERASE
K873378 · JQB
Catachem, Inc.
Chemistry · 15d
Cleared Sep 08, 1987
MODEL 690 SPECTROPHOTOMETER
K873408 · JJQ
Abbott Diagnostics
Chemistry · 14d
Cleared Sep 08, 1987
TEMPLATE
K873470 · FTY
Cox-Uphuff Intl.
General & Plastic Surgery · 11d
Cleared Sep 04, 1987
LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)
K863135 · GXZ
Neurotechnics, Inc.
Neurology · 385d
Cleared Sep 04, 1987
HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)
K863136 · GXZ
Neurotechnics, Inc.
Neurology · 385d
Cleared Sep 04, 1987
MULTIPLE
K863387 · DXK
Del Mar Avionics
Cardiovascular · 366d
Cleared Sep 04, 1987
FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
K870801 · FRN
Travenol Laboratories, S.A.
General Hospital · 189d
Cleared Sep 04, 1987
MODEL K210 AND K211 FLUIDOTHERAPY UNITS
K871802 · LSB
Henley Intl.
Physical Medicine · 119d
Cleared Sep 04, 1987
JMS NEEDLES AND JMS SYRINGES
K871965 · FMF
Jms Co., Ltd.
General Hospital · 108d
Cleared Sep 04, 1987
PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
K872228 · FNM
American Pharmaseal Div. Ahsc
General Hospital · 87d
Cleared Sep 04, 1987
INJECT-EASE
K872233 · KZH
Palco Laboratories, Inc.
General Hospital · 86d
Cleared Sep 04, 1987
WHIRLPOOL AERATOR WB700, WB800, WB900, WB975
K872327 · ILJ
Associated Mills, Inc.
Physical Medicine · 79d
Cleared Sep 04, 1987
ICOR NEONATAL HCH
K872371 · BYD
Icor AB
Anesthesiology · 77d
Cleared Sep 04, 1987
MIC MUSHROOM TIP GASTROSTOMY TUBE
K872531 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 70d
Cleared Sep 04, 1987
IRRIGATION PRESSURE MONITOR
K872544 · HRX
Avec Scientific Design Corp.
Orthopedic · 67d
Cleared Sep 04, 1987
SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM
K872590 · CAC
Solco Basle, Inc.
Anesthesiology · 65d
Cleared Sep 04, 1987
LASER CENTERING DEVICE
K872747 · HMR
Innomed Corp.
Ophthalmic · 53d
Cleared Sep 04, 1987
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · EFQ
Smith & Nephew, Inc.
General & Plastic Surgery · 53d
Cleared Sep 04, 1987
CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE
K872795 · FPA
Medex, Inc.
General Hospital · 58d
Cleared Sep 04, 1987
TROKEL SINGLE MIRROR YAG LASER LENS
K872802 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 51d
Cleared Sep 04, 1987
SAFETY SYRINGE
K872820 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 50d
Cleared Sep 04, 1987
ULTRA-NEB 99 ULTRASONIC NEBULIZER
K872826 · CAF
The Devilbiss Co.
Anesthesiology · 50d
Cleared Sep 04, 1987
BIOTROL ALPHA AMYLASE
K872831 · CIJ
Biotrol, USA, Inc.
Chemistry · 49d