Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
152617–152640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1984
POST-AID
K840907 · KCM
E.W. Link, Inc.
Ear, Nose, Throat · 156d
Cleared Aug 02, 1984
TIDAL DISTENSION IRRIGATION SET
K841362 · GBX
Abbott Laboratories
General & Plastic Surgery · 122d
Cleared Aug 02, 1984
QUINTON 901 & 900 HOLTER SCANNER
K841611 · DPS
Quinton, Inc.
Cardiovascular · 121d
Cleared Aug 02, 1984
ACU-DERM TRANSPARENT INCISE DRAPE
K841735 · KKX
Acme United Corp.
General Hospital · 98d
Cleared Aug 02, 1984
WOODLYN APPLANATION TONOMETER
K841762 · HKX
Woodlyn, Inc.
Ophthalmic · 97d
Cleared Aug 02, 1984
WOODLYN SLIT LAMP HSSL-EC
K841763 · HLI
Woodlyn, Inc.
Ophthalmic · 97d
Cleared Aug 02, 1984
COBE AEPS
K842054 · KRL
Cobe Laboratories, Inc.
Cardiovascular · 72d
Cleared Aug 02, 1984
ASCORBIC ACID
K842215 · FIP
Organon Teknika Corp.
Gastroenterology & Urology · 59d
Cleared Aug 02, 1984
PARTIALLY THREADED BONE FIX. PIN
K842293 · JDW
Warsaw Orthopedic, Inc.
Orthopedic · 50d
Cleared Aug 02, 1984
ULTRA LYTE ANALYZER I 100
K842315 · CEM
Ultra Quest Diagnostics, Inc.
Chemistry · 51d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY KIT
K842326 · DFH
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327 · DFT
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGG S7920-11
K842329 · DEW
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
AMER. HISTO-ID SYS PRIMARY IGA 2720-21
K842330 · CZP
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 50d
Cleared Aug 02, 1984
ALLIED ASSOC. THERAPEUTIC EXER EQUIP-
K842429 · BXB
Allied Associates, Inc.
Physical Medicine · 43d
Cleared Aug 02, 1984
ALLIED ASSOC. THERAP. EXERCISE EQUIP
K842430 · BXB
Allied Associates, Inc.
Physical Medicine · 43d
Cleared Aug 02, 1984
ALLIED ASSOC. THERAPEUTIC EXERCISE
K842433 · BXB
Allied Associates, Inc.
Physical Medicine · 43d
Cleared Aug 02, 1984
DISPOSABLE SURGERY HOOD
K842438
Anago, Inc.
General & Plastic Surgery · 42d
Cleared Aug 02, 1984
DISPOSABLE PREPING PAD
K842453
Anago, Inc.
General & Plastic Surgery · 41d
Cleared Aug 02, 1984
GX CEPH
K842463 · EAG
Gendex Corp.
Radiology · 41d
Cleared Aug 02, 1984
SURGICAL HEADLIGHT
K842515 · EBA
Good-Lite Co.
Dental · 51d
Cleared Aug 02, 1984
PDA SYSTEM
K842522 · JJG
Abbott Laboratories
Chemistry · 36d
Cleared Aug 02, 1984
BASE METAL ALLOY
K842551 · EJH
Dentsply Intl.
Dental · 31d
Cleared Aug 02, 1984
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT
K842623 · LJP
Syva Co.
Microbiology · 28d