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
153673–153696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1984
PARAMAX ALANINE AMINOTRANSFERASE
K840705 · CKA
American Dade
Hematology · 21d
Cleared Mar 08, 1984
ANTHROSCOPY SYSTEM
K834146 · HRX
Cabot Medical Corp.
Orthopedic · 98d
Cleared Mar 07, 1984
FOLEY CATHETERIZATION TRAY-VARIOUS
K832363 · KOD
Inmed Corp.
Gastroenterology & Urology · 233d
Cleared Mar 07, 1984
PHONATORY FUNCTION ANALYZER PS-77
K832678 · BXP
Kells Medical, Inc.
Anesthesiology · 211d
Cleared Mar 07, 1984
NO POUR BASIN
K840988
Concord Laboratories, Inc.
General Hospital
Cleared Mar 06, 1984
PORT-A-CATH IMPLANTABLE CATHETER SYS
K832906 · LLD
Pharmacia, Inc.
General Hospital · 190d
Cleared Mar 06, 1984
MESULIN INSULIN INFUSION SET
K833398 · FPA
Molnlycke A/S Hospital Products
General Hospital · 158d
Cleared Mar 06, 1984
HH SUBCUTANEOUS ACCESS PORT
K833672 · LKG
Holter-Hausner Intl.
General Hospital · 140d
Cleared Mar 06, 1984
MEDI-JECTOR II
K834044 · KZE
Derata Corp.
General Hospital · 104d
Cleared Mar 06, 1984
SILCATH
K834091 · LJS
Hdc Corp.
General Hospital · 99d
Cleared Mar 06, 1984
OP-CON SURG. INSTRUMENT #7
K834172 · EQN
Imm Enterprises , Ltd.
Ear, Nose, Throat · 106d
Cleared Mar 06, 1984
JAKOBI SURG. INSTRUMENTS #7 10/43
K834188 · JYL
Imm Enterprises , Ltd.
Ear, Nose, Throat · 106d
Cleared Mar 06, 1984
JAKOBI SURG. INSTRUMENTS #7 44/47
K834189 · EPY
Imm Enterprises , Ltd.
General & Plastic Surgery · 106d
Cleared Mar 06, 1984
JAKOBI SURG. INSTRUMENTS #8 15
K834190 · EMH
Imm Enterprises , Ltd.
Dental · 106d
Cleared Mar 06, 1984
CRYSTALLINE BONE SCREW ENDO-OSSEOUS
K834364 · DZE
C.B.S. Biotechnics, Inc.
Dental · 131d
Cleared Mar 06, 1984
SHOFU PORCELAIN STAIN
K834497 · EIH
Shofu Dental Corp.
Dental · 77d
Cleared Mar 06, 1984
OP-CON SURGICAL INSTRUMENT #9
K834540 · KBN
Imm Enterprises , Ltd.
Ear, Nose, Throat · 96d
Cleared Mar 06, 1984
HYPODERMIC SYRINGES & NEEDLES
K834548 · FMF
Cordis Corp.
General Hospital · 70d
Cleared Mar 06, 1984
INTRADISCAL THERAPY TRAY
K834553 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 70d
Cleared Mar 06, 1984
SURGICAL SUCTION INSTRUMENT-REUSABLE
K840007 · JOL
Lawton Surgical Instruments
General Hospital · 62d
Cleared Mar 06, 1984
PISTON SYRINGE DISPOS. STERILE SYRING
K840192 · FMF
Interexpo Corp.
General Hospital · 48d
Cleared Mar 06, 1984
CONCENTRATED PLATELET ADMIN. SET
K840212 · FPA
American Mcgaw
General Hospital · 47d
Cleared Mar 06, 1984
LOPEZ LOCK
K840273 · FPA
Icu Medical, Inc.
General Hospital · 43d
Cleared Mar 06, 1984
PAB IV CONTAINER
K840388 · KPE
American Mcgaw
General Hospital · 36d