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
141361–141384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1986
V100 VISUALLY EVOKED POTENTIAL MONITOR
K860910 · GWE
New Potentials, Inc.
Neurology · 282d
Cleared Dec 18, 1986
LKB ULTROBACT (TM) PNEUMOCOCCUS KIT
K862848 · GWC
Lkb Instruments, Inc.
Microbiology · 142d
Cleared Dec 18, 1986
METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.
K863492 · FAD
Surgitek
Gastroenterology & Urology · 100d
Cleared Dec 18, 1986
BUTTERFLY NON-CORING NEEDLE SET
K863606 · FMI
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 93d
Cleared Dec 18, 1986
MIC - CONCEPT(TM) RX-2
K863847 · JWY
Microtech Medical Systems, Inc.
Microbiology · 79d
Cleared Dec 18, 1986
DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT
K864133 · JLW
Diagnostic Systems Laboratories, Inc.
Chemistry · 58d
Cleared Dec 18, 1986
VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER
K864350 · FZP
Ethicon, Inc.
General & Plastic Surgery · 44d
Cleared Dec 18, 1986
STORZ SOLID & ANGLED SOLID CONTACT PROBES
K864398 · IYO
Storz Instrument Co.
Radiology · 42d
Cleared Dec 18, 1986
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
K864403 · LXT
Howmedica Corp.
Orthopedic · 38d
Cleared Dec 18, 1986
MANAN CONTRAST MEDIA ADMINISTRATION SET
K864405 · FPA
Manan Manufacturing Co., Inc.
General Hospital · 38d
Cleared Dec 18, 1986
SEAL SYRINGE (3CC,5CC,12CC,20CC,30CC & 50CC)
K864414 · FMF
Seal Syringe Corp.
General Hospital · 41d
Cleared Dec 18, 1986
ANGEL LATEX SURGICAL GLOVES
K864521 · KGO
Kim Intl. Trading Co.
General Hospital · 31d
Cleared Dec 18, 1986
TOWELS
K864528
Elof Hansson, Inc.
General & Plastic Surgery · 31d
Cleared Dec 18, 1986
STERILITE STERILIZATION KIT
K864596
Kimberly-Clark Corp.
General & Plastic Surgery · 27d
Cleared Dec 18, 1986
MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE.
K864631
Downs Surgical , Ltd.
Orthopedic · 23d
Cleared Dec 18, 1986
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633 · HWC
Howmedica Corp.
Orthopedic · 23d
Cleared Dec 18, 1986
EXTENSION SETS
K864692 · FPK
Salt Creek Medical Technologies
General Hospital · 16d
Cleared Dec 18, 1986
CK 6000 SERIES, TOWELS
K864697 · KKX
Currie Medical Specialties, Inc.
General Hospital · 16d
Cleared Dec 17, 1986
ELECTROPHORESIS DATA CENTER (EDC)
K860645 · JQT
Helena Laboratories
Chemistry · 300d
Cleared Dec 17, 1986
ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.
K863122 · FRC
Surgicot, Inc.
General Hospital · 125d
Cleared Dec 17, 1986
HOSPAL BIOSPAL 1800S
K863961 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 68d
Cleared Dec 17, 1986
MEDSURG CUSTOM SURGICAL SCRUB TRAYS
K864463
Medsurg Industries, Inc.
General & Plastic Surgery · 35d
Cleared Dec 17, 1986
SUNFIT SUNLAMP
K864485 · FTC
Sunfit, Inc.
General & Plastic Surgery · 34d
Cleared Dec 17, 1986
MODEL 668, TRACTION SPLINT, ADULT
K864765 · HST
Ferno-Washington, Inc.
Neurology · 12d