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
132625–132648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1989
DOUBLE ANTIBODY SERUM BENZODIAZEPINES
K890001 · JXM
Diagnostic Products Corp.
Toxicology · 21d
Cleared Jan 24, 1989
BAXTER STERILE TOWEL
K890006 · KKX
Healthmed Corp.
General Hospital · 21d
Cleared Jan 24, 1989
DISPOSABLE COLOR-CUFFS
K890014 · KCY
Instrumed, Inc.
General & Plastic Surgery · 21d
Cleared Jan 24, 1989
STERILE LACERATION TRAY
K890071 · LRP
Mumtaz I. Malik
General & Plastic Surgery · 15d
Cleared Jan 24, 1989
MODERN LATEX STERILE SURGICAL GLOVES
K890073 · KGO
Modern Rubber Co., Ltd. C/O World...
General Hospital · 15d
Cleared Jan 24, 1989
DANEK IRRIGATING BURR (DIB) SET
K890090 · GFF
Danek Medical, Inc.
General & Plastic Surgery · 14d
Cleared Jan 24, 1989
KLEEN TEST O.R. KIT
K890098 · LRO
Kleen Test Products
General & Plastic Surgery · 14d
Cleared Jan 24, 1989
BARD TAB ECG MONITORING ELECTRODE
K890103 · DRX
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Jan 24, 1989
MODIFIED CUSHION-FLEX(TM)
K890108 · BSJ
Life Design Systems, Inc.
Anesthesiology · 21d
Cleared Jan 24, 1989
BR-S601MU (SURGICAL VIDEO RECORDER)
K890119 · FWC
Victor Co. of Japan, Ltd. C/O Jvc Corp.
General & Plastic Surgery · 13d
Cleared Jan 24, 1989
ATS TB RAPID STAIN SET PRODUCT #034-45
K890148 · ICL
Alpha-Tec Systems, Inc.
Pathology · 11d
Cleared Jan 23, 1989
CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
K883327 · JGZ
Heraeus Kulzer, Inc.
Chemistry · 168d
Cleared Jan 23, 1989
ALBUWELL
K884146 · JIR
Exocell, Inc.
Chemistry · 112d
Cleared Jan 23, 1989
TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM
K884600 · JGJ
Technicon Instruments Corp.
Chemistry · 81d
Cleared Jan 23, 1989
TOTAL PROTEIN TEST (TP) ITEM #65670
K884703 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Jan 23, 1989
URIC ACID TEST (URIC) ITEM #65620
K884704 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Jan 23, 1989
28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM)
K884883 · DHB
Diagnostic Products Corp.
Immunology · 62d
Cleared Jan 23, 1989
COAT-A-COUNT (TM) THEOPHYLLINE
K890002 · KLS
Diagnostic Products Corp.
Toxicology · 20d
Cleared Jan 23, 1989
NEW LOW LEVEL DRUG MIXTURE CONTROL
K890030 · DIF
Rapid Diagnostic Laboratories, Inc.
Toxicology · 19d
Cleared Jan 23, 1989
V-TREND TARGET IM TEST
K890041 · KTN
Texas Immunology, Inc.
Immunology · 18d
Cleared Jan 19, 1989
MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM
K882609 · DRT
Waltham Div. Hewlett Packard
Cardiovascular · 206d
Cleared Jan 19, 1989
ARROW PNEUMOTHORAX KIT, AK-01500
K883905 · JOL
Arrow Intl., Inc.
General Hospital · 126d
Cleared Jan 19, 1989
VORTECH'S MEDICAL IMAGING GATEWAY
K884434 · LMD
Vortech Data, Inc.
Radiology · 91d
Cleared Jan 19, 1989
SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR
K884464 · JAX
Spirometrics, Inc.
Anesthesiology · 87d