FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90361–90384 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1998
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
K972919 · HWC
Bionx Implants, Inc.
Orthopedic · 232d
Cleared Mar 27, 1998
DUOCLIPPER TITANIUM CLIPS
K973652 · FZP
Scion International, Inc.
General & Plastic Surgery · 183d
Cleared Mar 27, 1998
KMC NEWSKIN
K974143 · MDA
Kmc Intl. Co.
General & Plastic Surgery · 144d
Cleared Mar 27, 1998
PHORESOR II, MODEL PM900
K974855 · KTB
Iomed, Inc.
Physical Medicine · 88d
Cleared Mar 27, 1998
CRANEX TOME CEPH, OR CRANEX TOME
K974877 · EHD
Orion Corporation Soredex
Radiology · 88d
Cleared Mar 27, 1998
E3 MICROPROBE
K974878 · GEX
Martin Uram, MD
General & Plastic Surgery · 87d
Cleared Mar 27, 1998
LASERSCOPE EL LASER SYSTEM AND ACCESSORIES
K974896 · GEX
Laserscope
General & Plastic Surgery · 86d
Cleared Mar 27, 1998
SOFSILK SUTURE
K980124 · GAP
United States Surgical, A Division of...
General & Plastic Surgery · 72d
Cleared Mar 27, 1998
DRUG CHECK
K980153 · DIO
Texas Immunology, Inc.
Toxicology · 70d
Cleared Mar 27, 1998
TRIANGLE SLING
K980482 · OTN
Influence, Inc.
Gastroenterology & Urology · 46d
Cleared Mar 27, 1998
FOTONA SKINPLUS LASER SYSTEM
K980560 · GEX
Fotona D.D.
General & Plastic Surgery · 42d
Cleared Mar 27, 1998
PARA-CARE
K980718 · IMC
Chattanooga Group, Inc.
Physical Medicine · 31d
Cleared Mar 27, 1998
3 MM SELEC-TIP LAPAROSCOPIC SCISSORS
K980758 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 28d
Cleared Mar 27, 1998
WINDMERE MODEL DS-2 FOOT BATH
K980769 · ILJ
Windmere Corp.
Physical Medicine · 28d
Cleared Mar 26, 1998
TECA NCS ELECTRODE SYSTEM 2000
K971914 · GXY
Medelec, Inc. D.B.A. Teca Corp.
Neurology · 307d
Cleared Mar 26, 1998
EA-D IGG ELISA TEST SYSTEM
K973123 · LSE
Clark Laboratories, Inc.
Microbiology · 218d
Cleared Mar 26, 1998
N-ASSAY CPK-L
K980900 · CGS
Crestat Diagnostics, Inc.
Chemistry · 16d
Cleared Mar 26, 1998
N-ASSAY L AST/GOT
K980902 · CIT
Crestat Diagnostics, Inc.
Chemistry · 16d
Cleared Mar 25, 1998
CROSS-CHECKS P
K972300 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 279d
Cleared Mar 25, 1998
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
K973419 · BTM
Nellcor Puritan Bennett, Inc.
Anesthesiology · 196d
Cleared Mar 25, 1998
ELECSYS CA 125II ON THE ELECSYS 1010
K980240 · LTK
Boehringer Mannheim Corp.
Immunology · 61d
Cleared Mar 25, 1998
MEDI-GRIP (BEIGE 43)SURGICAL GLOVES
K980564 · KGO
Ansell Perry
General Hospital · 40d
Cleared Mar 25, 1998
BCI 3401 HANDHELD PULSE OXIMETER
K980714 · DQA
Bci Intl., Inc.
Anesthesiology · 29d
Cleared Mar 25, 1998
NITRILE EXAM GLOVE, POWDER-FREE, BLUE
K980802 · LZA
Tucker & Associates
General Hospital · 23d