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
144265–144288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1986
AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N
K861251 · KNX
American Medical Products, Inc.
Gastroenterology & Urology · 15d
Cleared Apr 17, 1986
PERMABAND (ORTHODONTIC ADHESIVE)
K861258 · DYH
Ortho Source
Dental · 14d
Cleared Apr 17, 1986
SKIN MESH DEVICE
K861285 · GFD
Precision Modified Devices
General & Plastic Surgery · 10d
Cleared Apr 16, 1986
BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID
K854710 · KNN
Reloke Co.
Physical Medicine · 146d
Cleared Apr 16, 1986
ANGIOMED GUIED WIRES
K854912 · DQX
Angiomed U.S., Inc.
Cardiovascular · 128d
Cleared Apr 16, 1986
PMS PERCUTANEOUS PUNCTURE NEEDLE
K854941 · DYB
Professional Medical Services
Cardiovascular · 127d
Cleared Apr 16, 1986
DURAHESIVE PROTECTIVE BARRIER WIPE
K855019 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 121d
Cleared Apr 16, 1986
CURITY PERCUTANEOUS CATHETER INSERTION TRAY
K855060 · DYB
The Kendal Co.
Cardiovascular · 119d
Cleared Apr 16, 1986
CURITY PERCUTANEOUS CATHETER INSERTION KIT
K855061 · DYB
The Kendal Co.
Cardiovascular · 119d
Cleared Apr 16, 1986
37-701-1 PATIENT DOASE MONITOR WITH DETECTORS
K860469 · KPZ
Victoreen, Inc.
Radiology · 69d
Cleared Apr 16, 1986
ENZYMATIC URIC ACID REAGENT
K860732 · KNK
Trace Scientific , Ltd.
Chemistry · 49d
Cleared Apr 16, 1986
NON-CIRCULAR ORBITING OPTION
K861252 · KPS
Siemens Gammasonics, Inc.
Radiology · 13d
Cleared Apr 15, 1986
LIFE PAC
K854807 · KZD
Lifemed Technologies, Inc.
General Hospital · 133d
Cleared Apr 15, 1986
FC-1000 FLUOROSCOPIC IMAGING COMPUTER
K854810 · LLZ
Inficon Leybold-Heraeus, Inc.
Radiology · 133d
Cleared Apr 15, 1986
CD-200 CARDIAC MONITOR
K860175 · DPS
Cardio Display Corp.
Cardiovascular · 88d
Cleared Apr 15, 1986
MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC
K860278 · GEX
Britt Corp., Inc.
General & Plastic Surgery · 78d
Cleared Apr 15, 1986
PHOTRON VISUAL FIELD ANALYZER
K860642 · HOM
Biosan Laboratories, Inc.
Ophthalmic · 54d
Cleared Apr 15, 1986
BEHRING NEPHELOMETER SYSTEM
K860894 · CFN
Behring Diagnostics, Inc.
Immunology · 36d
Cleared Apr 15, 1986
STORZ/MAZZACCO LENS FORCEP
K860915 · HNR
Storz Instrument Co.
Ophthalmic · 35d
Cleared Apr 15, 1986
LM-850 AUTOMATIC LENSMETER
K861064 · HLM
Nidek, Inc.
Ophthalmic · 26d
Cleared Apr 15, 1986
SUEL BLOOD LANCET
K861151 · FMK
Exel Intl.
General & Plastic Surgery · 20d
Cleared Apr 15, 1986
ALBA HEALTH CARE PLAIN PACKING STRIP
K861154 · EFQ
Alba Health Care
General & Plastic Surgery · 18d
Cleared Apr 15, 1986
DEPUY COMPRESSION HIP SCREW SYSTEM
K861178 · KTT
Depuy, Inc.
Orthopedic · 15d
Cleared Apr 15, 1986
ACCUPAC CUSTOM SKIN SCRUB KIT
K861219
Geneva Laboratories, Inc.
General & Plastic Surgery · 14d