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
136537–136560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1988
DERMGARD SYSTEM 800 AND 900
K880486 · IOQ
Dermgard, Inc.
Physical Medicine · 18d
Cleared Feb 22, 1988
MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH
K880583 · MPB
Quinton, Inc.
Gastroenterology & Urology · 13d
Cleared Feb 19, 1988
HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR
K872441 · DPT
Advanced Technology Laboratories, Inc.
Cardiovascular · 245d
Cleared Feb 19, 1988
STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT
K873926 · JEY
Storz Instrument Co.
Dental · 147d
Cleared Feb 19, 1988
ASD-BIO ANTI-STICK DEVICE
K874602 · FMI
Biosurge, Inc.
General Hospital · 102d
Cleared Feb 19, 1988
HOLLYWOODS COOL SHADES
K874722 · HQY
Tonka Corp.
Ophthalmic · 93d
Cleared Feb 19, 1988
IMMPULSE DIGOXIN ASSAY REAGENTS
K874748 · LCS
Sclavo, Inc.
Toxicology · 93d
Cleared Feb 19, 1988
RAPID COLORIMETRIC DIRECT STREP A TEST
K874761 · GTZ
New Horizons Diagnostics Co.
Microbiology · 92d
Cleared Feb 19, 1988
COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.
K874838 · GKZ
Coulter Electronics, Inc.
Hematology · 87d
Cleared Feb 19, 1988
LASERTRIPTER MINISCOPE
K874858 · ODF
Candela Laser Corp.
Gastroenterology & Urology · 86d
Cleared Feb 19, 1988
FRESENIUS HEMOFLOW F3, F4, F5, F7
K874872 · FJI
Seratronics, Inc.
Gastroenterology & Urology · 84d
Cleared Feb 19, 1988
ACUSON TRANSPERINEAL NEEDLE GUIDE
K874922 · ITX
Acuson Computed Sonography
Radiology · 78d
Cleared Feb 19, 1988
CEMENT LINER
K874945 · EMA
Dentsply Intl.
Dental · 77d
Cleared Feb 19, 1988
STERILE SCRUBBY SCRUB BRUSH
K875033 · GEC
Medsurg Industries, Inc.
General & Plastic Surgery · 74d
Cleared Feb 19, 1988
PEYMAN G. 12.12 YAG LASER LENS
K875087 · HJK
Ocular Instruments, Inc.
Ophthalmic · 72d
Cleared Feb 19, 1988
HOSKINS-BARKAN GONIOTOMY LENS 9MM
K875114 · HJK
Ocular Instruments, Inc.
Ophthalmic · 67d
Cleared Feb 19, 1988
AMICON EQUALINE FLUID BALANCE SYSTEM
K875121 · KPF
Amicon, Inc.
Gastroenterology & Urology · 66d
Cleared Feb 19, 1988
LOW-POWER BINOCULAR LOUPE
K875124 · HOH
Seiler Instrument & Mfg. Co., Inc.
Ophthalmic · 66d
Cleared Feb 19, 1988
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
K875214 · LJT
Therex Corp.
General Hospital · 63d
Cleared Feb 19, 1988
UFR DIGITAL RETROFIT
K875312 · FJB
Yankee Intl. Medical Research & Mfg.,...
Gastroenterology & Urology · 52d
Cleared Feb 19, 1988
GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS
K880084 · FJI
Gambro, Inc.
Gastroenterology & Urology · 38d
Cleared Feb 19, 1988
FACTOR VIII REFERENCE PLASMA
K880292 · GJT
Helena Laboratories
Hematology · 25d
Cleared Feb 19, 1988
SEA - PORT INFUSION SET
K880297 · LJT
Harbor Medical Devices, Inc.
General Hospital · 25d
Cleared Feb 19, 1988
CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER
K880302 · GGN
Hemotec, Inc.
Hematology · 25d