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
136345–136368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 1988
MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD
K880551 · DTB
Intermedics, Inc.
Cardiovascular · 27d
Cleared Mar 04, 1988
NATURAL-TOUCH (TM) SURGEON'S GLOVE
K872996 · KGO
Hands-On Packaging , Ltd.
General Hospital · 214d
Cleared Mar 04, 1988
ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS
K874254 · LLO
Minnesota Laser Corp.
Anesthesiology · 136d
Cleared Mar 04, 1988
DISPOSABLE CAUTERIES
K874825 · GEI
Midsouth Industries, Inc.
General & Plastic Surgery · 100d
Cleared Mar 04, 1988
UMBILICAL ARTERY OXYGEN SENSOR
K875225 · CCE
Ohmeda Medical
Anesthesiology · 73d
Cleared Mar 04, 1988
STERILE EMPTY VIALS
K875227 · LDH
Allertech, Inc.
General Hospital · 73d
Cleared Mar 04, 1988
LUMBAR IMPACTION SET
K875290 · KWP
T. Korossurgical Instruments Corp.
Orthopedic · 65d
Cleared Mar 04, 1988
DAEWOO LATEX SURGICAL GLOVE
K880035 · KGO
California Ent.
General Hospital · 59d
Cleared Mar 04, 1988
BLADE, SURGICAL PREP RAZOR STRAIGHT
K880048 · LDQ
Crescent Corp.
General & Plastic Surgery · 58d
Cleared Mar 04, 1988
PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
K880150 · HWE
Dyonics, Inc.
Orthopedic · 51d
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