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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
78265–78288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
K011570 · MVM
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jul 09, 2001
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
K011668 · MSQ
Oridion Medical 1987 , Ltd.
Microbiology · 53d
Cleared Jul 09, 2001
BW ACUPUNCTURE NEEDLES
K011669 · MQX
H F Intl. Co.
General Hospital · 40d
Cleared Jul 09, 2001
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE,...
K011728 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 35d
Cleared Jul 09, 2001
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Jul 09, 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864 · DTN
Medtronic Vascular
Cardiovascular · 25d
Cleared Jul 09, 2001
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND...
K011895 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 21d
Cleared Jul 06, 2001
AMIGO WHEELCHAIR
K010503 · INI
Amigo Mobility Intl., Inc.
Physical Medicine · 135d
Cleared Jul 06, 2001
GLOBAL FX POROUS-COATED HUMERAL STEM
K011099 · MBF
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Jul 06, 2001
CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
K011243 · LSB
Chattanooga Group, Inc.
Physical Medicine · 74d
Cleared Jul 06, 2001
PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
K011787 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 05, 2001
TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS
K003818 · DZE
Titan Implants
Dental · 206d
Cleared Jul 05, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
K010668 · LFX
Bayer Corp.
Microbiology · 121d
Cleared Jul 05, 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · HWC
Osteomed Corp.
Orthopedic · 97d
Cleared Jul 05, 2001
PREMIUM
K011130 · ELM
Heraeus Kulzer, Inc.
Dental · 83d
Cleared Jul 05, 2001
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
K011170 · HRS
Synthes (Usa)
Orthopedic · 79d
Cleared Jul 05, 2001
MOBILE-PATIENT VIEWER
K011436 · DPS
Data Critical Corporation
Cardiovascular · 56d
Cleared Jul 05, 2001
IN TEN-S
K011492 · EBF
Ivoclar North America, Inc.
Dental · 51d
Cleared Jul 05, 2001
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713 · LZA
Kimberly-Clark Corp.
General Hospital · 31d
Cleared Jul 05, 2001
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
K011731 · JJY
Medical Analysis Systems, Inc.
Chemistry · 30d
Cleared Jul 05, 2001
POWDERED LATEX EXAMINATION GLOVES
K011922 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 15d
Cleared Jul 03, 2001
PRAIRIE CRUISER
K002580 · ITI
Raye'S, Inc.
Physical Medicine · 319d
Cleared Jul 03, 2001
BODYSTAT
K002835 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 294d
Cleared Jul 03, 2001
SMART RAD
K003438 · MQB
Cmt Medical Technologies, Ltd.
Radiology · 239d