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
152377–152400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 05, 1984
SCANLAN VASCU-STATT II
K841515 · HRG
Scanlan Intl., Inc.
Ophthalmic · 54d
Cleared Jun 05, 1984
OREIA II B-HCG PREGNANCY TEST KIT
K841525 · JHI
Organon, Inc.
Chemistry · 54d
Cleared Jun 05, 1984
AXIOM THORACIC CATHETERS
K841593
Axiom Medical, Inc.
General & Plastic Surgery · 48d
Cleared Jun 05, 1984
ELECATH HEPARIN-COATED CATHETERS
K841615 · DQO
Electro-Catheter Corp.
Cardiovascular · 64d
Cleared Jun 05, 1984
TIMEX HEALTHCHECK DIGITAL BP MONITOR
K841616 · DXN
Timex Medical Products Corp.
Cardiovascular · 35d
Cleared Jun 05, 1984
MAXIMAX - 4
K841649 · IZP
Cgr Medical Corp.
Radiology · 46d