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
136681–136704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1988
VITAACCESS (TM) CATHETER INTRODUCER SYSTEM
K872998 · FOZ
Vitaphore Corp.
General Hospital · 234d
Cleared Mar 24, 1988
MOBAY (BAYER) MAKROLON 2658 1112
K873820 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
GE NORYL 731-80089S
K873821 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
MOBAY (BAYER) MERLON M-40 (H)F 1112
K873822 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
MOBAY (BAYER) MAKROLON 2658 3291
K873823 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000
K873824 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
GE LEXAN 144R 112
K873825 · LRX
Applied Laboratories, Inc.
Ophthalmic · 185d
Cleared Mar 24, 1988
INET MODEL BIOVISION
K873834 · HCC
Inet Corp.
Neurology · 185d
Cleared Mar 24, 1988
LARYNGECTOMY TUBE
K873992 · KAC
Portex, Inc.
Ear, Nose, Throat · 175d
Cleared Mar 24, 1988
MEDCO MEMORY RETRACTOR SYSTEM
K874829 · GZT
Medical Equipment Development Co., Inc.
Neurology · 121d
Cleared Mar 24, 1988
CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)
K874875 · CEC
Boots-Celltech Diagnostics, Inc.
Chemistry · 118d
Cleared Mar 24, 1988
WESBLOT PROCESSOR
K874887 · KPA
American Bionetics, Inc.
Chemistry · 114d
Cleared Mar 24, 1988
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K875334 · HGL
Kontron Instruments, Inc.
Obstetrics & Gynecology · 85d
Cleared Mar 24, 1988
OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
K875350 · BSZ
Ohmeda Medical
Anesthesiology · 84d
Cleared Mar 24, 1988
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K875371 · HGL
Kontron Instruments, Inc.
Obstetrics & Gynecology · 84d
Cleared Mar 24, 1988
STA-SET I.V. FLOW REGULATOR
K880006 · LDR
Controlled Flow , Ltd.
General Hospital · 80d
Cleared Mar 24, 1988
EBV-NA TEST
K880043 · LLM
Gull Laboratories, Inc.
Microbiology · 78d
Cleared Mar 24, 1988
ABBOTT IMX HCG
K880070 · JHI
Abbott Laboratories
Chemistry · 72d
Cleared Mar 24, 1988
MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
K880170 · LLO
Cooper Lasersonics, Inc.
Anesthesiology · 69d
Cleared Mar 24, 1988
MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
K880173 · HHR
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 69d
Cleared Mar 24, 1988
THEOPHYLLINE TEST KIT REF. #A874799
K880291 · LCA
Photec Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY
K880296 · CFT
London Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
WAKO(TM) AUTOKIT TOTAL PROTEIN
K880312 · CEK
Wako Chemicals USA, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
WAKO(TM) AUTOKIT ALBUMIN
K880313 · CIX
Wako Chemicals USA, Inc.
Chemistry · 59d