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
151225–151248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1984
HASTINGS BIPOLAR ENDOPROSTHESIS
K842344 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 90d
Cleared Sep 12, 1984
PM 2000 DENTAL UNIT
K842357 · EIA
Planmeca USA, Inc.
Dental · 82d
Cleared Sep 12, 1984
OXALATE URINE CONTROLS NORMAL & ELEVAT
K842366 · JJW
Sigma Chemical Co.
Chemistry · 89d
Cleared Sep 12, 1984
HEMOPERFUSION PROCEDURE W/REDY 2000
K842513 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 78d
Cleared Sep 12, 1984
SUCROSEP THYROID STIMULATING HORMONE
K842593 · JLW
Boots-Celltech Diagnostics, Inc.
Chemistry · 71d
Cleared Sep 12, 1984
BRITISH SPINAL FUSION SET
K842698 · FZX
Downs Surgical , Ltd.
General & Plastic Surgery · 63d
Cleared Sep 12, 1984
BASILDON-GARDNER SPINAL FRAME
K842700 · FWZ
Downs Surgical , Ltd.
General & Plastic Surgery · 63d
Cleared Sep 12, 1984
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
K842874 · JTA
American Micro Scan
Microbiology · 51d
Cleared Sep 12, 1984
DECOLORIZING FLUIC, ACID-ALCOHOL 3%
K842934 · PPM
E K Ind., Inc.
Pathology · 49d
Cleared Sep 12, 1984
ACETIC ACID, 5% V/V
K842935 · GGK
E K Ind., Inc.
Hematology · 49d
Cleared Sep 12, 1984
ACETIC ACID, 3% V/V
K842936 · GGK
E K Ind., Inc.
Hematology · 49d
Cleared Sep 12, 1984
ACETIC ACID 2% V/V
K842937 · GGK
E K Ind., Inc.
Hematology · 49d
Cleared Sep 12, 1984
APPLELISA CHLAMYDIA TRACHOMATIS ANTI
K843120 · LJC
Apple Diagnostic Products
Microbiology · 35d
Cleared Sep 12, 1984
RADIONICS MINI & STANDARD SHUNT VALVE
K843132 · JXG
Radionics, Inc.
Neurology · 34d
Cleared Sep 12, 1984
EMIT 700 CALIBRATOR A
K843163 · DKB
Syva Co.
Toxicology · 33d
Cleared Sep 12, 1984
AMIKACIN ANALYTICAL TEST PACK ACA
K843211 · KLQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 28d
Cleared Sep 12, 1984
STRATUS QUINIDINE FLUOROMETRIC ENZYME
K843237 · LBZ
American Dade
Toxicology · 21d
Cleared Sep 12, 1984
KAPP SPINAL BUTTON
K843368 · HTN
Kapp Surgical Instrument, Inc.
Orthopedic · 15d
Cleared Sep 12, 1984
PATIENT GUIDED KNEE EXERCISER
K843493 · BXB
Richards Medical Co., Inc.
Physical Medicine · 6d
Cleared Sep 11, 1984
FUKUDA DENSHI FX-302 AUTO/THREE CHAN
K833594 · DRT
Brentwood Instruments, Inc.
Cardiovascular · 335d
Cleared Sep 11, 1984
AXIPAC II
K834539
Teknar, Inc.
Ophthalmic · 272d
Cleared Sep 11, 1984
GIARDIA GUARD
K842052 · LIB
Gelman Sciences, Inc.
Microbiology · 112d
Cleared Sep 11, 1984
DIA T1, T2 & T3
K842286 · JPK
Diatech, Inc.
Hematology · 90d
Cleared Sep 11, 1984
SABA-COOMBS MINI EXTERNAL FIXATOR
K842343 · JEC
Zimmer, Inc.
Orthopedic · 89d