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
132409–132432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · DRX
C.R. Bard, Inc.
Cardiovascular · 21d
Cleared Mar 22, 1989
ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)
K891098 · DBL
Immco Diagnostics, Inc.
Immunology · 20d
Cleared Mar 22, 1989
ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)
K891099 · DBL
Immco Diagnostics, Inc.
Immunology · 20d
Cleared Mar 22, 1989
PATIENT EXAMINATION GLOVE
K891132 · LYZ
Phoenix Medical Technology, Inc.
General Hospital · 19d
Cleared Mar 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891153 · LYY
K.B. Latex Products Sdn. Bhd.
General Hospital · 16d
Cleared Mar 22, 1989
TITAN GEL IFE TRIVALENT ANTISERUM
K891188 · CFQ
Helena Laboratories
Immunology · 16d
Cleared Mar 22, 1989
LATEX EXAMINATION GLOVES
K891205 · LYY
Ming Hsien Rubber Industrial Co.
General Hospital · 16d
Cleared Mar 22, 1989
LATEX EXAMINATION GLOVES
K891207 · LYY
Chung Yuan Rubber & Plastics Co.
General Hospital · 16d
Cleared Mar 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891209 · LYY
Chung Yuan Trading Co., Ltd.
General Hospital · 16d
Cleared Mar 22, 1989
IQ/QCA PHOSPHORUS
K891218 · CEO
Bd Becton Dickinson Vacutainer...
Chemistry · 15d
Cleared Mar 22, 1989
SINTON LATEX EXAMINATION GLOVE
K891220 · LYY
Sinton Latex Chemical Industries Co.,...
General Hospital · 15d
Cleared Mar 22, 1989
PATIENT EXAMINATION GLOVES
K891232 · LYY
Supergrade Healthcare Products Sdn. Bhd.
General Hospital · 15d
Cleared Mar 22, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891245 · LYY
Terang Nusa Sdn Bhd
General Hospital · 14d
Cleared Mar 22, 1989
UROLOGICAL LOOP RETRIEVERS
K891252 · FGO
Northgate Research, Inc.
Gastroenterology & Urology · 14d
Cleared Mar 22, 1989
UROLOGICAL GRASPING FORCEPS
K891253 · FGO
Northgate Research, Inc.
Gastroenterology & Urology · 14d
Cleared Mar 22, 1989
UROLOGICAL STONE BASKET
K891254 · FFL
Northgate Research, Inc.
Gastroenterology & Urology · 14d
Cleared Mar 22, 1989
DEFEND LATEX EXAMINATION GLOVES
K891257 · LYY
Carl Parker Associates, Inc.
General Hospital · 14d
Cleared Mar 22, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891271 · LYY
Dr. Boo Co., Ltd.
General Hospital · 13d
Cleared Mar 22, 1989
MID-LEVEL IGG KIT CAT. NO. 9315
K891299 · DAQ
Helena Laboratories
Immunology · 9d
Cleared Mar 22, 1989
CAMPION LASER FORCEPS
K891348 · GEN
Simpson/Basye, Inc.
General & Plastic Surgery · 12d
Cleared Mar 21, 1989
SAF FECAL COLLECTION KIT
K885244 · JSM
Precision Biologicals, Inc.
Microbiology · 89d
Cleared Mar 21, 1989
CARY-BLAIR TRANSPORT SYSTEM
K885245 · JSM
Precision Biologicals, Inc.
Microbiology · 89d
Cleared Mar 21, 1989
PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT
K890768 · LYF
Genetic Systems Corp.
Microbiology · 34d
Cleared Mar 21, 1989
BIOTROL URINE PROTEINS REAGENT
K890846 · JIR
Biotrol, USA, Inc.
Chemistry · 28d