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
170329–170352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1978
MODEL 7320 VISUAL STIMULATOR
K781461 · GWE
Life-Tech Instruments, Inc.
Neurology · 82d
Cleared Nov 08, 1978
PNEUMATIC VITRECTOMY CONTROL UNIT
K781471 · HQE
Helfgott Medical Instruments
Ophthalmic · 72d
Cleared Nov 08, 1978
ANTITHROMBIN III ASSAY
K781480 · JBQ
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 72d
Cleared Nov 08, 1978
THE VISUAL SPEECH AID
K781522 · LFA
Exeter Medical Labs, Inc.
Ear, Nose, Throat · 64d
Cleared Nov 08, 1978
NEPHELRATE ANTISERUMS C3C
K781653 · CZW
Antibodies, Inc.
Immunology · 42d
Cleared Nov 08, 1978
NEPHELRATE ANTIPERUMS LGM
K781654 · CFN
Antibodies, Inc.
Immunology · 42d
Cleared Nov 08, 1978
NEPHELRATE ANTISERUMS 1GA
K781655 · CFN
Antibodies, Inc.
Immunology · 42d
Cleared Nov 08, 1978
NEPHELRATE ANTISERUMS, IGG
K781656 · CFN
Antibodies, Inc.
Immunology · 42d
Cleared Nov 08, 1978
RIA, T3 UPTAKE SOLID PHASE
K781662 · KHQ
Bd Becton Dickinson Vacutainer...
Chemistry · 41d
Cleared Nov 08, 1978
ACU-DOT
K781672
Acu-Dot Pharmaceutical Intl., Inc.
General & Plastic Surgery · 36d
Cleared Nov 08, 1978
SPLINT, HOAKE INFLATABLE AIR
K781754 · KQZ
Depuy, Inc.
Orthopedic · 22d
Cleared Nov 08, 1978
SANI-DENT DENTURE CLEANER
K781779 · JER
Sandi-Dent
Dental · 156d
Cleared Nov 08, 1978
BOARD, DISPOSABLE CONTROL COUNT
K781791 · MMK
Dexide, Inc.
General Hospital · 19d
Cleared Nov 08, 1978
PREP TRAY, PREOPERATIVE SKIN
K781797 · OJU
Pharmaseal Div., Baxter Healthcare Corp.
General & Plastic Surgery · 16d
Cleared Nov 08, 1978
TRANSFER PAK 4R 9006
K781811 · KSR
Travenol Laboratories, S.A.
Hematology · 13d
Cleared Nov 08, 1978
SULFATE, FIBRIQUIK PROTAMINE
K781814 · JBN
General Diagnostics
Hematology · 13d
Cleared Nov 08, 1978
BONE CLAMP, ACE EXTERNAL
K781839 · JEC
Ace Orthopedic Manufacturing Co.
Orthopedic · 12d
Cleared Nov 08, 1978
EXTERNAL ARTICULATION
K781840 · JEC
Ace Orthopedic Manufacturing Co.
Orthopedic · 12d
Cleared Nov 08, 1978
BAR, DISTRACTION
K781841 · JEC
Ace Orthopedic Manufacturing Co.
Orthopedic · 12d
Cleared Nov 08, 1978
OXYGENATOR, BLOOD BOS-10
K781842 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 12d
Cleared Nov 07, 1978
TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN
K780573 · LCP
Bd Becton Dickinson Vacutainer...
Hematology · 211d
Cleared Nov 07, 1978
GLYCOHEMOGLOBIN-SKREEN TEST KIT
K780819 · LCP
Eppendorf-Brinkmann, Inc.
Hematology · 174d
Cleared Nov 07, 1978
ANGIOGRAPHIC GUIDE WIRE
K781561 · DQX
Wilson Medical Instruments Co.
Cardiovascular · 56d
Cleared Nov 07, 1978
STIMULATOR, E.S.I. NEURO
K781670 · GZJ
Evolutionary Systems, Inc.
Neurology · 35d