Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
153217–153240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 1984
WI-38
K841806 · KIR
Viromed Laboratories, Inc.
Pathology · 37d
Cleared Jun 07, 1984
PHARMACIA IGE RIA
K841824 · DGC
Pharmacia, Inc.
Immunology · 36d
Cleared Jun 07, 1984
PHADEBAS RAST PHADEZYM RAST ALLERGEN
K841829 · DGC
Pharmacia, Inc.
Immunology · 35d
Cleared Jun 07, 1984
AMER. MED. OPTICS ARGON/KRYPTON LASER
K841856 · HQF
American Medical Optics
Ophthalmic · 35d
Cleared Jun 07, 1984
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT
K841892 · CIG
Reagents Applications, Inc.
Chemistry · 31d
Cleared Jun 07, 1984
SPECTACLE FRAMES
K841908 · HQZ
Cosmas Optical USA , Ltd.
Ophthalmic · 30d
Cleared Jun 07, 1984
CM-TRISACRYL M DEAE-TRISACRYL M
K842028 · KEA
Lkb Instruments, Inc.
Chemistry · 20d
Cleared Jun 07, 1984
MACLEAN-FOGG, DISPOS-INOCULA-LOOPS
K842057 · LIB
Polymer Technology Corp.
Microbiology · 16d
Cleared Jun 07, 1984
L-ALANINE-4-NITROANILIDE
K842072 · JSF
Irvine Diagnostic Services
Microbiology · 15d
Cleared Jun 07, 1984
RIM SPOT INDOLE
K842097 · JSF
Austin Biological Laboratories
Microbiology · 13d
Cleared Jun 07, 1984
MACCONKEY AGAR, PLUS
K842100 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 13d
Cleared Jun 07, 1984
COBA AGAR
K842101 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 13d
Cleared Jun 07, 1984
ALLERCOAT ALLERGEN DISCS
K842125 · DGC
Kallestad Laboratories, Inc.
Immunology · 9d
Cleared Jun 05, 1984
SURGICAL ISOLATION BARRIER SYSTEM
K831531
Lone Star Medical Products, Inc.
General & Plastic Surgery · 391d
Cleared Jun 05, 1984
YTTRO FILTER
K833779 · IZW
Yttro Corp.
Radiology · 222d
Cleared Jun 05, 1984
LEAP FROG
K834211 · DSI
Philips Medical Systems (Cleveland),...
Cardiovascular · 183d
Cleared Jun 05, 1984
FLUOROSCOPIC IMAGE INTENSIFIER
K840621 · JAA
Phoenix Radiology, Ltd.
Radiology · 112d
Cleared Jun 05, 1984
TEMPROBE MONITOR
K840648 · FLL
Vital Signs, Inc.
General Hospital · 111d
Cleared Jun 05, 1984
ELECTRO SURGERY SYSTEM
K841165 · GEY
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 78d
Cleared Jun 05, 1984
ANTRUM NEEDLE-WOLF TYPE
K841300
Popper & Sons, Inc.
Orthopedic · 67d
Cleared Jun 05, 1984
GARDNER TYPE BONE MARROW NEEDLE
K841301 · GAA
Popper & Sons, Inc.
General & Plastic Surgery · 67d
Cleared Jun 05, 1984
ND62T THYROID UPTAKE SYSTEM
K841440 · IZD
Nuclear Data, Inc.
Radiology · 60d
Cleared Jun 05, 1984
PMA ANGIOGRAPHY TRAY
K841468 · DWS
Professional Medical Services
Cardiovascular · 57d
Cleared Jun 05, 1984
SCANLAN VASCU-STATT II APPROXIMATOR
K841514 · HRQ
Scanlan Intl., Inc.
General & Plastic Surgery · 54d