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
78049–78072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2001
POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K011995 · LYY
Quality Latex Products Malaysia Sdn Bhd
General Hospital · 35d
Cleared Jul 31, 2001
MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
K012099 · LLZ
Totoku Electric Co., Ltd.
Radiology · 26d
Cleared Jul 31, 2001
PASS SPINAL SYSTEM
K012175 · MNI
Encore Orthopedics, Inc.
Orthopedic · 19d
Cleared Jul 31, 2001
EFILM WORKSTATION
K012211 · LLZ
Efilm Medical, Inc.
Radiology · 15d
Cleared Jul 31, 2001
SCALPFIX CLIP SYSTEM
K012219 · HBO
Aesculap, Inc.
General & Plastic Surgery · 15d
Cleared Jul 31, 2001
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
K012251 · JWH
Exactech, Inc.
Orthopedic · 13d
Cleared Jul 30, 2001
BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
K010734 · MLK
Branan Medical Corp.
Chemistry · 140d
Cleared Jul 30, 2001
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
K011052 · JMM
Ostex Intl., Inc.
Chemistry · 115d
Cleared Jul 30, 2001
RADS
K011054 · DIO
Chason Healthcare, LLC
Toxicology · 115d
Cleared Jul 30, 2001
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
K011353 · DJG
ACON Laboratories, Inc.
Toxicology · 88d
Cleared Jul 30, 2001
MITYVAC
K011532 · HDB
Prism Enterprises, Inc.
Obstetrics & Gynecology · 73d
Cleared Jul 30, 2001
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
K011662 · DDG
The Binding Site, Ltd.
Immunology · 62d
Cleared Jul 30, 2001
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
K011663 · DEM
The Binding Site, Ltd.
Immunology · 62d
Cleared Jul 27, 2001
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL...
K002336 · IPF
Apex Medical Corp.
Physical Medicine · 360d
Cleared Jul 27, 2001
WELL-TENS
K002874 · GZJ
Well-Life Consultant
Neurology · 316d
Cleared Jul 27, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010159 · LTT
Dade Microscan, Inc.
Microbiology · 191d
Cleared Jul 27, 2001
QUANTA PLEX ENA PROFILE 4
K011140 · LLL
Inova Diagnostics, Inc.
Immunology · 105d
Cleared Jul 27, 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 27, 2001
SYNTHS ONE-THIRD TUBULAR DCL PLATE
K011335 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 27, 2001
HYDRO2, HS-75
K011914 · HQD
Innovision, Inc.
Ophthalmic · 38d
Cleared Jul 27, 2001
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
K012028 · LFL
Misonix, Inc.
General & Plastic Surgery · 29d
Cleared Jul 27, 2001
BRAUN PRECISION SENSOR PRO, MODEL BP 2590
K012035 · DXN
Braun GmbH
Cardiovascular · 28d
Cleared Jul 27, 2001
MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
K012060 · ELC
Hu-Friedy Mfg. Co., Inc.
Dental · 25d
Cleared Jul 27, 2001
KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
K990667 · NEI
KLS-Martin L.P.
Dental · 878d