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
90937–90960 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1998
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
K973938 · JJQ
Sfri, Inc.
Chemistry · 112d
Cleared Feb 04, 1998
CLEARLINE PLUS, DENTAL WATERLINE FILTER
K973996 · EIA
Scitech Solutions, Inc.
Dental · 106d
Cleared Feb 04, 1998
FLEXIBLE TIP DIGITAL THERMOMETER
K974195 · FLL
K-Jump Health Co., Ltd.
General Hospital · 89d
Cleared Feb 04, 1998
PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM
K974203 · MQU
Integrated Orbital Implants, Inc.
Ophthalmic · 86d
Cleared Feb 04, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974213 · MNH
United States Surgical, A Division of...
Orthopedic · 86d
Cleared Feb 04, 1998
DENTAL TRAY, STERILE, DISPOSABLE
K974238 · EIA
Trinity Laboratories, Inc.
Dental · 84d
Cleared Feb 04, 1998
GLUMA ONE BOND
K974390 · KLE
Heraeus Kulzer, Inc.
Dental · 75d
Cleared Feb 04, 1998
QUICKSCREEN ONE STEP PCP SCREENING TEST
K974582 · LCM
Phamatech
Toxicology · 58d
Cleared Feb 04, 1998
PARAGON LENS CARE
K974635 · LRX
Paragon Vision Sciences
Ophthalmic · 54d
Cleared Feb 04, 1998
ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT...
K974839 · MMI
First Medical, Inc.
Chemistry · 42d
Cleared Feb 04, 1998
AMYLASE
K980013 · CIJ
Ac Biochemicals, Inc.
Chemistry · 33d
Cleared Feb 04, 1998
CARESIDE ALBUMIN
K980041 · CIX
Exigent Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 04, 1998
CARESIDE TOTAL PROTEIN
K980042 · CEK
Exigent Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 04, 1998
T-UPTAKE MICROPLATE EIA
K980088 · KHQ
Monobind
Chemistry · 26d
Cleared Feb 03, 1998
MEDTRONIC MODEL 3998 LEAD
K971756 · GZB
Medtronic Vascular
Neurology · 267d
Cleared Feb 03, 1998
NON-REBREATHING 'T' (BE 117)
K973066 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 169d
Cleared Feb 03, 1998
RESPOSABLE BARE FIBERS
K973172 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 162d
Cleared Feb 03, 1998
SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE
K973596 · OLW
Spacelabs Medical, Inc.
Neurology · 134d
Cleared Feb 03, 1998
TYTRON C-3000
K974208 · HCS
Titronics Research & Development Co.
Neurology · 85d
Cleared Feb 03, 1998
LYSONIX IRRIGATION SYSTEM
K974233 · GBX
Lysonix, Inc.
General & Plastic Surgery · 83d
Cleared Feb 03, 1998
CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
K974320 · OCL
Cryogen, Inc.
Cardiovascular · 78d
Cleared Feb 03, 1998
3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL...
K974553 · GEI
3M Healthcare
General & Plastic Surgery · 78d
Cleared Feb 03, 1998
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
K980196 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 14d
Cleared Feb 02, 1998
RUMORS DYNAMIC AIR THERAPY UNIT
K972111 · IKZ
Hill-Rom, Inc.
Physical Medicine · 242d