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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
135193–135216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1988
SYNCHRON CX(TM)4 CLINICAL ANALYZER
K881498 · JJE
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Jun 01, 1988
EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647
K881607 · DLF
Em Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Jun 01, 1988
DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID
K881612 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 50d
Cleared Jun 01, 1988
STERILE SURGEONS GLOVES
K881756 · KGO
Packaging Technologies, Inc.
General Hospital · 37d
Cleared Jun 01, 1988
MINILINE BRACKET
K881789 · EJF
Alexotek Co.
Dental · 36d
Cleared Jun 01, 1988
REP LIPO KIT CAT. NO 3180
K881809 · JHO
Helena Laboratories
Chemistry · 34d
Cleared Jun 01, 1988
STERILE SURGICAL LATEX GLOVE
K881821 · KGO
Nca Med Intl./Noble House, Inc.
General Hospital · 33d
Cleared Jun 01, 1988
OLYMPIA II
K881860 · EJT
J.F. Jelenko & Co., Inc.
Dental · 29d
Cleared Jun 01, 1988
PTM-45
K881861 · EJT
J.F. Jelenko & Co., Inc.
Dental · 29d
Cleared Jun 01, 1988
PERMA-PIC PLASTIC TOOTHPICK
K881900 · JET
The Perma-Pic Co.
Dental · 26d
Cleared Jun 01, 1988
AUDINA
K882004 · ESD
American Audio Services, Inc.
Ear, Nose, Throat · 19d
Cleared May 31, 1988
MODEL 7200A, PRESSURE VENTILATION OPTION
K873151 · CBK
Puritan Bennett Corp.
Anesthesiology · 294d
Cleared May 31, 1988
MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM
K874663 · BZL
Ametek/Thermox Instruments Division
Anesthesiology · 200d
Cleared May 31, 1988
IMPLANTABLE ELECTRODE LEAD, MODEL 030-446
K874664 · DTB
Telectronics, Inc.
Cardiovascular · 200d
Cleared May 31, 1988
ACS FUNNEL INTRODUCER
K875158 · DYB
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 168d
Cleared May 31, 1988
HORIZON 9000
K875167 · DXG
Mennen Medical, Inc.
Cardiovascular · 167d
Cleared May 31, 1988
TRI-FLOW CATHETER
K875205 · JXG
Neurodynamics, Inc.
Neurology · 165d
Cleared May 31, 1988
PAR(TM) BRAND DRUG OF ABUSE CONTROLS
K880152 · DIF
Medical Analysis Systems, Inc.
Toxicology · 139d
Cleared May 31, 1988
DENVER PERITONEO-VENOUS SHUNT
K880401 · KPM
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 123d
Cleared May 31, 1988
INCOS 50 MASS SPECTROMETER
K880418 · DOP
Finnigan Corp.
Toxicology · 120d
Cleared May 31, 1988
STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II
K880545 · GXY
Stimwear
Neurology · 112d
Cleared May 31, 1988
URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C
K880584 · CDM
Mach Diag. C/O Wichita State University
Chemistry · 111d
Cleared May 31, 1988
THERAPEUTIC DRUG STANDARD
K880705 · DKB
Verichem Laboratories, Inc.
Toxicology · 99d
Cleared May 31, 1988
STERILE NEEDLE FOR BLOOD COLLECTION
K880746 · FMI
Applied Plastics Technology, Inc.
General Hospital · 97d