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
124921–124944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1990
CRI CYNOSAR CATHETER
K900320 · DRA
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 234d
Cleared Sep 14, 1990
ACSYS SHEARER ACETABULAR CUP PROSTHESIS
K900435 · LWJ
3M Company
Orthopedic · 227d
Cleared Sep 14, 1990
ROTABLATOR
K901206 · MCW
Heart Technology, Inc.
Cardiovascular · 184d
Cleared Sep 14, 1990
VINYL SILICONE ELASTOMER MATERIAL
K901990 · MDA
Crown Delta Corp.
General & Plastic Surgery · 135d
Cleared Sep 14, 1990
SILICONE ELASTOMER PUTTY
K901991 · MDA
Crown Delta Corp.
General & Plastic Surgery · 135d
Cleared Sep 14, 1990
K-CAP-I ORTHOPEDIC FIXATION WIRE CAP
K902053 · LYT
Westcon Orthopedics, Inc.
Orthopedic · 130d
Cleared Sep 14, 1990
CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM
K902374 · FRN
Pharmacia Deltec, Inc.
General Hospital · 107d
Cleared Sep 14, 1990
MICROGUARD, ORTHOPEDIC PIN PROTECTORS
K902676 · LYT
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 87d
Cleared Sep 14, 1990
BIOSEARCH ANAL BIOFEEDBACK DEVICE
K902843 · FAP
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 14, 1990
BIOSITE DIAGNOSTICS OPIATE SCREENING TEST
K902924 · DJG
Biosite Incorporated
Toxicology · 74d
Cleared Sep 14, 1990
NEOS (TM) 02 B PULSE GENERATOR
K903081 · DXY
Biotronik, GmbH & Co.
Cardiovascular · 64d
Cleared Sep 14, 1990
RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT
K903123 · JIQ
Reagents Applications, Inc.
Chemistry · 60d
Cleared Sep 14, 1990
SELECT 20, DENTAL ALLOY
K903484 · EJT
Leach and Dillon Co., Inc.
Dental · 45d
Cleared Sep 14, 1990
SANOFLEX-STERILE LATEX SURGICAL GLOVES
K903513 · KGO
Lowenkamp Intl., Inc.
General Hospital · 42d
Cleared Sep 14, 1990
SAFETY INJECTION PORT
K903541 · FPA
Du-Call Miller Plastics, Inc.
General Hospital · 38d
Cleared Sep 14, 1990
CINTEX
K903605 · ILQ
Nanopac, Inc.
Physical Medicine · 37d
Cleared Sep 14, 1990
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
K903650 · HWE
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 32d
Cleared Sep 14, 1990
OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
K903713 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 31d
Cleared Sep 14, 1990
GOLD GATORS
K903729 · DRY
Lead-Lok, Inc.
Cardiovascular · 29d
Cleared Sep 13, 1990
TEFLON CERVICAL ACCESS SET
K896701 · HDQ
Cook Ob/Gyn
Obstetrics & Gynecology · 289d
Cleared Sep 13, 1990
EUB-515 DIAGNOSTIC ULTRASOUND DEVICE
K897042 · IYO
Hitachi Medical Corp. of America
Radiology · 269d
Cleared Sep 13, 1990
SERIM RESIDUAL CHLORINE TEST KIT
K901734 · FKJ
Serim Research Corp.
Gastroenterology & Urology · 149d
Cleared Sep 13, 1990
PDS-2000
K902653 · EIK
Intl. Equipment and Supply Corp.
Dental · 90d
Cleared Sep 13, 1990
DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002
K902692 · FAP
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 86d