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
131833–131856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 21, 1989
HEMATASTAT H-70
K890849 · GKG
Separation Technology, Inc.
Hematology · 28d
Cleared Mar 21, 1989
LATEX EXAMINATION GLOVES
K891204 · LYY
Advance Rubber, Inc.
General Hospital · 15d
Cleared Mar 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891208 · LYY
Cho FU Industrial Co., Ltd.
General Hospital · 15d
Cleared Mar 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891242 · LYY
Dr. Boo Co., Ltd.
General Hospital · 14d
Cleared Mar 20, 1989
10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC
K882274 · DSP
Kontron Instruments, Inc.
Cardiovascular · 293d
Cleared Mar 20, 1989
9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON
K882508 · DSP
Kontron Instruments, Inc.
Cardiovascular · 276d
Cleared Mar 20, 1989
OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
K890011 · BZO
Life Design Systems, Inc.
Anesthesiology · 76d
Cleared Mar 20, 1989
AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)
K890708 · JJY
Amersham Corp.
Chemistry · 48d
Cleared Mar 20, 1989
DMA MICROPROTEIN PROCEDURE
K890868 · CEK
Data Medical Associates, Inc.
Chemistry · 27d
Cleared Mar 17, 1989
ADMS SILENT NEEDLE GUN
K882746 · KNW
Advanced Diagnostic Medical Systems,...
Gastroenterology & Urology · 255d
Cleared Mar 17, 1989
DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.
K883842 · ELW
Dentsply Intl.
Dental · 186d
Cleared Mar 17, 1989
BRACKET TABLE ARM COVER
K884219 · EIA
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
AIR WATER SYRINGE TIP SHIELD
K884220 · EFS
Steri-Shield Products, Inc.
Dental · 162d
Cleared Mar 17, 1989
ULTRASONIC SCALER COVER
K884221 · ELC
Steri-Shield Products, Inc.
Dental · 162d