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
133297–133320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1988
HIGH RISK NEEDLE CONNECTOR ASSEMBLY
K884264 · FPA
Venture Molded Products, Inc.
General Hospital · 34d
Cleared Nov 14, 1988
PREMIER DIE-TRAK ARTICULATOR
K884418 · EJP
Premier Medical
Dental · 25d
Cleared Nov 14, 1988
STAMEY NEEDLE
K884553 · GEJ
Cook Ob/Gyn
General & Plastic Surgery · 14d
Cleared Nov 14, 1988
TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS
K884584 · BWB
Eastmed Enterprises, Inc.
Anesthesiology · 12d
Cleared Nov 10, 1988
CREATINE KINASE (CK) ISOENZYME MB
K881168 · JHT
Data Medical Associates, Inc.
Chemistry · 237d
Cleared Nov 10, 1988
PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE
K881426 · NAD
Laboratoire Pan-Pra
General & Plastic Surgery · 219d
Cleared Nov 10, 1988
HYGEIA URINE PREGNANCY TEST
K882192 · DHA
Hygeia Sciences
Chemistry · 169d
Cleared Nov 10, 1988
TURBOX THEOPHYLLINE ASSAY
K882570 · LER
Unipath , Ltd.
Toxicology · 141d
Cleared Nov 10, 1988
KODAK SURECELL CHLAMYDIA TEST KIT
K882923 · LJC
Eastman Kodak Company
Microbiology · 120d
Cleared Nov 10, 1988
SATURNE 42 AND 43
K883019 · IYE
General Electric Co.
Radiology · 114d
Cleared Nov 10, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
K883621 · LNH
Instrumentarium Corp.
Radiology · 77d
Cleared Nov 10, 1988
PROBE(TM) MODELS 700 AND 1000
K883749 · JQW
Packard Instrument Co., Inc.
Chemistry · 70d
Cleared Nov 10, 1988
CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE
K883813 · JKA
Ciba Corning Diagnostics Corp.
Chemistry · 63d
Cleared Nov 10, 1988
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
K883816 · KWS
Osteonics Corp.
Orthopedic · 63d
Cleared Nov 10, 1988
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
K883942 · JJY
Icl Scientific
Toxicology · 52d
Cleared Nov 10, 1988
MAGNESIUM REAGENT (MAGON SULFONATE)
K883972 · JGJ
Sigma Chemical Co.
Chemistry · 51d
Cleared Nov 10, 1988
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
K884021 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Nov 10, 1988
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100 · JLS
Amersham Corp.
Chemistry · 43d
Cleared Nov 10, 1988
MACROPORE MEDICAL/SURGICAL PAPER TAPE
K884108 · KGX
Lectec Corp.
General & Plastic Surgery · 42d
Cleared Nov 10, 1988
MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS)
K884181 · GEN
Sales & Marketing Assoc.
General & Plastic Surgery · 38d
Cleared Nov 10, 1988
DELFIA (TM) HIGE KIT
K884545 · DGC
Pharmacia, Inc.
Immunology · 10d
Cleared Nov 10, 1988
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
K884548 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Nov 10, 1988
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Nov 09, 1988
SENSOCOR(TM) R-TEST 240 XL
K881772 · DXH
Sensormedix, Inc.
Cardiovascular · 197d