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
174169–174192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1976
RESP. AIR TEMP. CONTROL & HAZARD MON.
K761295 · BZE
Harris-Lake, Inc.
Anesthesiology · 9d
Cleared Dec 30, 1976
PRE-FILLED DISPOSABLE NEBULIZER
K761298 · CAF
Mcgaw Respiratory Therapy
Anesthesiology · 9d
Cleared Dec 30, 1976
DISPOSABLE NEBULIZER
K761299 · CAF
Mcgaw Respiratory Therapy
Anesthesiology · 9d
Cleared Dec 30, 1976
NEBULIZER CONTROL UNIT
K761300 · CAF
Mcgaw Respiratory Therapy
Anesthesiology · 9d
Cleared Dec 30, 1976
IMMU-SAL IMMUNOHEMATOLOGICAL SALINE
K761303 · KSS
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 8d
Cleared Dec 30, 1976
CENTRIA T3 RIA
K761305 · CDP
Union Carbide Corp.
Immunology · 8d
Cleared Dec 30, 1976
OB-GYN CONTROL SERA (CODE 196300)
K761309 · JIX
Amersham Corp.
Immunology · 7d
Cleared Dec 30, 1976
ACCRAASSAY RID KITS
K761311 · JZQ
Miles Laboratories, Inc.
Immunology · 7d
Cleared Dec 30, 1976
SYNTEX SYSTEM 6000
K761330 · JAK
Syntex Corp.
Radiology · 3d
Cleared Dec 30, 1976
HI-SENSITIVITY MODE OPTION FOR S60-1A
K761332 · JAK
Syntex Corp.
Radiology · 3d
Cleared Dec 29, 1976
SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY
K760749 · JJC
Gilford Instrument Laboratories, Inc.
Chemistry · 90d
Cleared Dec 29, 1976
GOLDFARB LIVER CLAMP
K760898 · GDJ
Edward Weck, Inc.
General & Plastic Surgery · 64d
Cleared Dec 29, 1976
AIR PURIFIER
K760921 · FRF
Vitaire Corp.
General Hospital · 62d
Cleared Dec 29, 1976
INTERSORB LAPAROTOMY SPONGE
K761037 · EFQ
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 44d
Cleared Dec 29, 1976
AUTO-INORGANIC PHOSPHORUS REAGENT
K761238 · CEO
Harleco
Chemistry · 16d
Cleared Dec 29, 1976
AUTO-INORGANIC PHOSPHORUS REAGENT
K761239 · CEO
Harleco
Chemistry · 16d
Cleared Dec 29, 1976
AUTO-ENZYMATIC GLUCOSE
K761240 · CFR
Harleco
Chemistry · 16d
Cleared Dec 29, 1976
ENZYMATIC BUN (RATE) REAGENT KIT
K761261 · CDQ
Beckman Instruments, Inc.
Chemistry · 13d
Cleared Dec 29, 1976
TRIGLYCERIDES (LIPASE) REAGENT SET
K761262 · CDT
Worthington Biochemical Corp.
Chemistry · 13d
Cleared Dec 29, 1976
CHOLESTEROL AUTOMATED REAGENT
K761263 · CHH
Worthington Biochemical Corp.
Chemistry · 13d
Cleared Dec 29, 1976
GEMENI GPT (ALT) ASSAY
K761269 · CKA
Electro-Nucleonics Laboratories, Inc.
Chemistry · 13d
Cleared Dec 29, 1976
PET-SCOPE
K761285 · JAA
Diagnostic Information, Inc.
Radiology · 9d
Cleared Dec 28, 1976
ELECTROSURGICAL DISPERSIVE PLATE
K760675 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 102d
Cleared Dec 28, 1976
POCKET TRANSMITTER (PT-10)
K761073 · DXH
Eldeco
Cardiovascular · 39d