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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
72937–72960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2002
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · MQV
Synthes (Usa)
Orthopedic · 29d
Cleared Dec 19, 2002
SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND...
K024011 · NLU
Surgical Instruments Service and...
Gastroenterology & Urology · 15d
Cleared Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · JFY
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Dec 18, 2002
ANTI-SNORING DEVICE OR ASD
K011723 · LRK
Pi Medical
Dental · 562d
Cleared Dec 18, 2002
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 126d
Cleared Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
K022944 · MSV
Hycor Biomedical, Inc.
Immunology · 104d
Cleared Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
K022945 · MSV
Hycor Biomedical, Inc.
Immunology · 104d
Cleared Dec 18, 2002
LAPARETTE, MODEL LAP J L S H N
K022979 · KNF
Instruments Medicaux G.B., Inc.
Obstetrics & Gynecology · 100d
Cleared Dec 18, 2002
ACE VERSANAIL
K023115 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Dec 18, 2002
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
K023119 · HTN
Arthrex, Inc.
Orthopedic · 90d
Cleared Dec 18, 2002
COALESCENT U-CLIP- AND ACCESSORIES
K023125 · NJU
Coalescent Surgical
General & Plastic Surgery · 90d
Cleared Dec 18, 2002
ANDREWS INTRODUCER, MODEL ASI01
K023173 · MDM
Andrews Surgical Innovations, Ltd.
General & Plastic Surgery · 86d
Cleared Dec 18, 2002
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
K023225 · BZG
Puritan Bennett Corp.
Anesthesiology · 82d
Cleared Dec 18, 2002
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K023271 · FMF
Terumo Medical Corp.
General Hospital · 78d
Cleared Dec 18, 2002
GROSHONG NXT DUAL LUMEN PICC CATHETERS
K023374 · LJS
C.R. Bard, Inc.
General Hospital · 71d
Cleared Dec 18, 2002
GOLD CORE 35
K023501 · EJT
Pentron Laboratory Technologies
Dental · 61d
Cleared Dec 18, 2002
JEWEL CAST PLUS
K023502 · EJH
Pentron Laboratory Technologies
Dental · 61d
Cleared Dec 18, 2002
BURETTE-IN LINE (150 ML)
K023595 · FPA
Tuta Healthcare Pty Limited
General Hospital · 51d
Cleared Dec 18, 2002
POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE
K023702 · LZA
Ningbo Tianshun Rubber Products Co.,...
General Hospital · 47d
Cleared Dec 18, 2002
ST AIA-PACK CEA ENZYME IMMUNOASSAY
K023893 · DHX
Tosoh Medics, Inc.
Immunology · 26d
Cleared Dec 18, 2002
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA...
K023907 · KNQ
Cordis Corp.
Gastroenterology & Urology · 23d
Cleared Dec 18, 2002
ALOKA SSD-3500 ULTRASOUND SYSTEM
K023996 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Dec 18, 2002
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
K024025 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 12d
Cleared Dec 18, 2002
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K024026 · LYZ
Shanghai PM Plastics Enterise Co., Ltd.
General Hospital · 12d