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
96745–96768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1996
OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
K962152 · JWH
Osteonics Corp.
Orthopedic · 71d
Cleared Aug 14, 1996
DALL-MILES TROCHANTER CABLE SUPERGRIP
K962162 · JDQ
Howmedica Corp.
Orthopedic · 71d
Cleared Aug 14, 1996
EAGLE EYES SUNGLASSES
K962287 · HQY
Positive Response Television
Ophthalmic · 61d
Cleared Aug 14, 1996
NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES
K962461 · LZA
Shen Wei (Usa), Inc.
General Hospital · 50d
Cleared Aug 14, 1996
PROCAINAMIDE ENZYME IMMUNOASSAY
K962463 · LAR
Diagnostic Reagents, Inc.
Toxicology · 50d
Cleared Aug 14, 1996
NHMC IRRIGATION TRAY
K962670 · LJH
National Healthcare Mfg. Corp.
Gastroenterology & Urology · 36d
Cleared Aug 14, 1996
BIPOLAR PENCIL COAGULATOR
K962678 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 35d
Cleared Aug 14, 1996
SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
K962789 · GEY
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 28d
Cleared Aug 13, 1996
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614 · ELW
Dentsply Intl.
Dental · 435d
Cleared Aug 13, 1996
MICROSELECTRON-HDR VERSION 2
K953946 · JAQ
Nucletron-Oldelft Corp.
Radiology · 358d
Cleared Aug 13, 1996
THE AMPLATZ THROMBECTOMY DEVICE
K954205 · MCW
Microvena Corp.
Cardiovascular · 341d
Cleared Aug 13, 1996
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
K961814 · GIZ
Cardiovascular Diagnostics, Inc.
Hematology · 95d
Cleared Aug 13, 1996
PEEP VALVE
K961867 · BYE
Medical Marketing Concepts
Anesthesiology · 90d
Cleared Aug 13, 1996
RMI HEMOCONCENTRACTOR TUBING SET
K961927 · DWF
Research Medical, Inc.
Cardiovascular · 88d
Cleared Aug 13, 1996
S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)
K961939 · LPH
Johnson & Johnson Professionals, Inc.
Orthopedic · 85d
Cleared Aug 13, 1996
TRS 2000 TELERADIOLOGY SYSTEM
K961983 · LLZ
Sectra-Imtec AB
Radiology · 85d
Cleared Aug 13, 1996
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
K962082 · KWS
Osteonics Corp.
Orthopedic · 76d
Cleared Aug 13, 1996
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K962476 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 49d
Cleared Aug 12, 1996
GLOVE, EXAMINATION, VINYL
K952050 · LYZ
Oak Carolina, Inc.
General Hospital · 469d
Cleared Aug 12, 1996
DAVID BACK CLINIC SYSTEM
K952163 · ISD
Kinetic Resources, Inc.
Physical Medicine · 462d
Cleared Aug 12, 1996
BRAINLAB HEADPINS
K954789 · HAW
Brainlab AG
Neurology · 299d
Cleared Aug 12, 1996
D. DEVICE II
K955742 · DXC
Yousef Daneshvar
Cardiovascular · 237d
Cleared Aug 12, 1996
INPUT TUOHY-BORST LOCKING DEVICE
K960445 · DYB
C.R. Bard, Inc.
Cardiovascular · 193d
Cleared Aug 12, 1996
HYCOAT
K960686 · MGQ
The Hymed Group Corp.
General & Plastic Surgery · 174d