Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136945–136968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1988
ACKRAD PEDIATRIC C.P.A.P. SYSTEM
K880161 · BYE
Ackrad Laboratories
Anesthesiology · 51d
Cleared Mar 04, 1988
TSRH H/M HOOK HOLDER
K880211 · KWP
Warsaw Orthopedic, Inc.
Orthopedic · 45d
Cleared Mar 04, 1988
TSRH H/M HOOK HOLDER W/ROD MOVER
K880212 · KWP
Warsaw Orthopedic, Inc.
Orthopedic · 45d
Cleared Mar 04, 1988
MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.
K880216 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 44d
Cleared Mar 04, 1988
INSPIRON NEBULO BASIC EXTERNAL HEATER
K880304 · CAF
Intertech Resources, Inc.
Anesthesiology · 39d
Cleared Mar 04, 1988
PATELLAR TENDON GRAFT GUIDE
K880413 · LXH
Concept, Inc.
Orthopedic · 32d
Cleared Mar 04, 1988
RESUSCI PATIENT FACE SHIELD
K880450 · BTM
Laerdal Medical Corp.
Anesthesiology · 31d
Cleared Mar 04, 1988
CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
K880571 · LJT
Catheter Technology Corp.
General Hospital · 23d
Cleared Mar 04, 1988
ACCO(R) FACE MASK
K880613 · FXX
Absorbent Cotton Co., Inc.
General Hospital · 17d
Cleared Mar 04, 1988
TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING
K880649 · GXY
Labeltape Meditect, Inc.
Neurology · 16d
Cleared Mar 03, 1988
GAMBRO-ENGSTROM ERICA IV RESPIRATOR
K872482 · CBK
Gambro, Inc.
Anesthesiology · 254d
Cleared Mar 03, 1988
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290
K874481 · LDR
Y
General Hospital · 122d
Cleared Mar 03, 1988
ARC ADAPTER ASSEMBLY
K874833 · HAW
Medical Equipment Development Co., Inc.
Neurology · 100d
Cleared Mar 03, 1988
GLUCOSE (HEXOKINASE)
K874846 · CFR
Tech-Co, Inc.
Chemistry · 100d
Cleared Mar 03, 1988
TECHNICON CHEM 1(TM) SYSTEM
K874916 · LDR
Technicon Instruments Corp.
Chemistry · 91d
Cleared Mar 03, 1988
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60
K874946 · IZO
Shimadzu Precision Instruments, Inc.
Radiology · 92d
Cleared Mar 03, 1988
MENTOR UNISTENT URETERAL STENT SET
K875038 · FAD
Mentor Corp.
Gastroenterology & Urology · 87d
Cleared Mar 03, 1988
CIBA CORNING MODEL 644
K875098 · JXR
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Mar 03, 1988
SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE
K875213 · LJT
Titan Medical, Inc.
General Hospital · 76d
Cleared Mar 03, 1988
NH REPLACEMENT GASTROSTOMY KIT
K880232 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 43d
Cleared Mar 03, 1988
INSTANT EOSIN-ALCOHOLIC
K880240 · HYB
Shandon, Inc.
Pathology · 43d
Cleared Mar 03, 1988
AST (SGOT) REAGENT SET
K880276 · CIT
Tech-Neal Scientific, Inc.
Chemistry · 42d
Cleared Mar 03, 1988
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE
K880388 · CDP
Serono Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 03, 1988
TARGET STREP A
K880460 · GTZ
V-Tech, Inc.
Microbiology · 29d