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
132145–132168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1989
CERVICAL BIOPSY FORCEPS
K890380 · HFB
Kinetic Medical Products
Obstetrics & Gynecology · 35d
Cleared Feb 27, 1989
COMPRESSION FORCEPS
K890382 · HFW
Kinetic Medical Products
Obstetrics & Gynecology · 35d
Cleared Feb 27, 1989
MALLEABLE PLACENTA CURETTE
K890387 · HEX
Kinetic Medical Products
Obstetrics & Gynecology · 35d
Cleared Feb 27, 1989
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY
K890409 · GGP
Baxter Healthcare Corp
Hematology · 34d
Cleared Feb 27, 1989
PMS ANGIO DRAPE
K890471 · KKX
Professional Medical Services
General Hospital · 27d
Cleared Feb 27, 1989
RUG BUG WHEEL CHAIR
K890490 · ITI
Sinties Scientific, Inc.
Physical Medicine · 27d
Cleared Feb 27, 1989
MICROLITE TUBE LUMINOMETER #011-902-0000
K890502 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 26d
Cleared Feb 27, 1989
SURE COUNT LIGHT HANDLE COVER
K890539 · FTA
Kleen Test Products
General & Plastic Surgery · 24d
Cleared Feb 27, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
K890540 · CGS
Abbott Laboratories
Chemistry · 24d
Cleared Feb 27, 1989
NIDEK AR-1200
K890559 · HKO
Nidek, Inc.
Ophthalmic · 21d
Cleared Feb 27, 1989
MOLTENO IMPLANT
K890598 · KYF
Iop, Inc.
Ophthalmic · 21d
Cleared Feb 27, 1989
SUTTER HOSPITAL CPM
K890607 · BXB
Sutter Corp.
Physical Medicine · 21d
Cleared Feb 27, 1989
ACUFEX CANNULATED SCREWS, WASHERS, BONE PLATES
K890641 · HRS
Acufex Microsurgical, Inc.
Orthopedic · 19d
Cleared Feb 27, 1989
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
K890749 · JPK
R&D Systems, Inc.
Hematology · 14d
Cleared Feb 24, 1989
CRIS ADAPTER
K883986 · FPA
Y
General Hospital · 157d
Cleared Feb 24, 1989
MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD
K884688 · KWP
Synthes (Usa)
Orthopedic · 108d
Cleared Feb 24, 1989
HOLD-FAST DENTURE ADHESIVE
K884999 · KOL
Iodent, Co.
Dental · 85d
Cleared Feb 24, 1989
CLINISTAT HEMOGLOBIN REAGENT TEST
K885227 · KHG
Heraeus Kulzer, Inc.
Hematology · 66d
Cleared Feb 24, 1989
BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT
K885241 · FNJ
King Mfg. Co.
General Hospital · 65d
Cleared Feb 24, 1989
ATS LUGOL'S IODINE SOLUTION
K890020 · JTS
Alpha-Tec Systems, Inc.
Pathology · 51d
Cleared Feb 24, 1989
BIOTRACK APTT REAGENT CARTRIDGE
K890052 · GFO
Biotrack, Inc.
Hematology · 49d
Cleared Feb 24, 1989
MDP DISPOSABLE SYRINGE
K890155 · FMF
Mediplas Marketing
General Hospital · 38d
Cleared Feb 24, 1989
KODAK MIN-R 2 CASSETTE
K890361 · IXA
Eastman Kodak Company
Radiology · 30d
Cleared Feb 24, 1989
CP&S GAVAGE CONSTAINER, DISPOSABLE
K890552 · KNT
Consolidated Products & Services, Inc.
Gastroenterology & Urology · 18d