FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125905–125928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1990
PHYSICIAN BARRIER GLOVE, SURGICAL
K901221 · LYU
Dynamic Marketing Ent.
General Hospital · 118d
Cleared Jul 10, 1990
CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA.
K901500 · CHJ
Olympus Corp.
Chemistry · 103d
Cleared Jul 10, 1990
MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM
K901613 · CGA
Medisense, Inc.
Chemistry · 95d
Cleared Jul 10, 1990
LITTER, FOLDING RIGID POLE, DECONTAMINABLE
K901760 · FPP
Dept. of the Army
General Hospital · 83d
Cleared Jul 10, 1990
PLEURA BIOPSY DEVICE
K901995 · GDM
Mill-Rose Laboratory
General & Plastic Surgery · 69d
Cleared Jul 10, 1990
TENONE(TM) OPIATES CATALOG: VKSO1,4
K902055 · DDE
Diagnostic Products Corp.
Toxicology · 64d
Cleared Jul 10, 1990
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700
K902061 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 64d
Cleared Jul 10, 1990
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700
K902148 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 56d
Cleared Jul 10, 1990
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
K902483 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 10, 1990
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM
K902536 · JJY
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Jul 10, 1990
STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES
K902567 · JDR
A. Henniss
Orthopedic · 29d
Cleared Jul 10, 1990
SODIUM REAGENT SET
K902572 · CEI
Tech Intl. Co.
Chemistry · 29d
Cleared Jul 10, 1990
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM
K902573 · JJY
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Jul 10, 1990
POTASSIUM REAGENT SET
K902574 · CEJ
Tech-Co, Inc.
Chemistry · 29d
Cleared Jul 10, 1990
EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2
K902578 · DKB
Syva Co.
Toxicology · 29d
Cleared Jul 10, 1990
MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS
K902635 · EMA
Confi-Dental Products Co.
Dental · 28d
Cleared Jul 10, 1990
ATAC 6000 CHEMISTRY ANALYZER
K902689 · JJE
Bio-Chem Laboratories
Chemistry · 21d
Cleared Jul 10, 1990
IMX ULTRASENTITIVE HTSH
K902753 · JLW
Abbott Mfg., Inc.
Chemistry · 18d
Cleared Jul 10, 1990
TACTYLON TM SURGICAL GLOVE
K902831 · KGO
Tactyl Technologies, Inc.
General Hospital · 12d
Cleared Jul 09, 1990
TFV-2300 INFUSION PUMP
K890736 · FRN
Nihon Kohden America, Inc.
General Hospital · 511d
Cleared Jul 09, 1990
SONICAID MODEL VASOFLO 4
K895909 · MAA
Oxford Medilog, Inc.
Radiology · 272d
Cleared Jul 09, 1990
BABY BOARDS IV SUPPORT ASSEMBLY
K900134 · KMK
Baby Boards, Inc.
General Hospital · 180d
Cleared Jul 09, 1990
ULTRASOUND SCANNER MODEL #1150
K900469 · IYO
Pie Medical USA BV
Radiology · 159d
Cleared Jul 09, 1990
CYANODONT DENTAL CEMENT
K901082 · EMA
Specialites Septodont
Dental · 124d