FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
135769–135792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1988
KERR XR BOND
K880250 · EMA
Kerr Corporation (Danbury)
Dental · 133d
Cleared Jun 01, 1988
KERR XR IONOMER
K880251 · EMA
Kerr Corporation (Danbury)
Dental · 133d
Cleared Jun 01, 1988
FACTOR II PROSTHETIC SILICONE ELASTOMER
K880329 · GBI
Factor, Ii, Inc.
General & Plastic Surgery · 127d
Cleared Jun 01, 1988
SAFESKIN STERILE SURGEONS GLOVES
K880446 · KGO
Safeskin Corp.
General Hospital · 120d
Cleared Jun 01, 1988
LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE
K880591 · HHR
Laser Peripherals, LLC
Obstetrics & Gynecology · 111d
Cleared Jun 01, 1988
SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER
K880900 · HEM
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 91d
Cleared Jun 01, 1988
PUDENDAL/LOCAL ANESTESIA BLOCK TRAY
K880988 · KNE
Bd Becton Dickinson Vacutainer...
Obstetrics & Gynecology · 85d
Cleared Jun 01, 1988
CONTAC, A DENTIN SEALANT
K881026 · LBH
Harry J. Bosworth Co.
Dental · 83d
Cleared Jun 01, 1988
ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.
K881185 · HEM
Philips Medical Systems (Cleveland),...
Obstetrics & Gynecology · 72d
Cleared Jun 01, 1988
RIA-QUICK
K881194 · JQP
Quantitative Technologies, Inc.
Chemistry · 72d
Cleared Jun 01, 1988
ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE
K881224 · GAE
Acufex Microsurgical, Inc.
General & Plastic Surgery · 71d
Cleared Jun 01, 1988
IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225
K881351 · JHY
Intl. Immunoassay Laboratories, Inc.
Chemistry · 63d
Cleared Jun 01, 1988
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474 · CFJ
Abbott Laboratories
Chemistry · 55d
Cleared Jun 01, 1988
SYNCHRON CX(TM)5 CLINICAL ANALYZER
K881495 · JJE
Beckman Instruments, Inc.
Chemistry · 54d
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