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
130993–131016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1989
ACCU-BEAM YAG FIBER
K890922 · GEX
Tti Medical
General & Plastic Surgery · 80d
Cleared May 15, 1989
ORTHOPAEDIC STAPLES
K890962 · JDR
Ortho Spectrum, Inc.
Orthopedic · 77d
Cleared May 15, 1989
COHN TARGETEER
K891903 · LXH
Orthopedic Systems, Inc.
Orthopedic · 49d
Cleared May 15, 1989
SAFE-T-FACE DISPOSABLE FACE SHIELD
K892451 · FXX
Barry S. Smith Co.
General Hospital · 35d
Cleared May 15, 1989
ELECTROSURGICAL PENCIL
K892502 · GEI
Yuntek International, Inc.
General & Plastic Surgery · 34d
Cleared May 15, 1989
ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA
K892887 · FIQ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 25d
Cleared May 12, 1989
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
K884557 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 193d
Cleared May 12, 1989
LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER)
K890440 · LYY
Tomarc (M) Sdn Bhd
General Hospital · 105d
Cleared May 12, 1989
LANGS EXAM GLOVE
K890776 · LYY
Langs Intl., Inc.
General Hospital · 86d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES
K891195 · LYY
Nbs Maronix Rubber Co. , Ltd.
General Hospital · 67d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891389 · LYY
Rubberex (M) Sdn Berhad
General Hospital · 58d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891417 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 59d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891422 · LYY
United Fortune International, Inc.
General Hospital · 59d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891423 · LYY
J'Joy Intl., Inc.
General Hospital · 59d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891435 · LYY
Safeskin Corp.
General Hospital · 58d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891547 · LYY
Huaguang Waterproof Material Co., Ltd.
General Hospital · 56d
Cleared May 12, 1989
VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)
K891726 · LYZ
Baldur Systems Corp.
General Hospital · 50d
Cleared May 12, 1989
LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD)
K891727 · LYY
Baldur Systems Corp.
General Hospital · 50d
Cleared May 12, 1989
ALMATEX PATIENT EXAMINATION GLOVES (LATEX)
K891748 · LYY
Healthgard Medical Products Ltd....
General Hospital · 51d
Cleared May 12, 1989
HYGEIA EXAMINATION GLOVES
K891805 · LYY
Hygeia , Ltd.
General Hospital · 50d
Cleared May 12, 1989
BUD BRAND PATIENT EXAMINATION GLOVES (LATEX)
K891836 · LYY
Associated Ent., Inc.
General Hospital · 46d
Cleared May 12, 1989
VINYL EXAM GLOVES, C&K STYLE #1025FS
K891848 · LYZ
C & K Mfg. & Sales Co.
General Hospital · 46d
Cleared May 12, 1989
ADDWEALTH LATEX EXAMINATION GLOVES
K891934 · LYY
Precision Trading Intl., Inc.
General Hospital · 45d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K891945 · LYZ
Libent Co., Ltd.
General Hospital · 45d